Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard electrical stimulation device with pre-programmed settings and no mention of AI or ML capabilities.

Therapeutic

Yes
The device is intended for therapeutic uses such as managing chronic pain, increasing range of motion, preventing muscle atrophy, and relaxing muscle spasms, all of which are treatment-oriented indications.

Diagnostic

No

The device is intended for therapeutic purposes like muscle re-education, pain relief, and prevention of disuse atrophy through electrical stimulation, not for identifying the presence or absence of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable, two-channel; battery operated system" and includes a "control unit, are a lead wire assembly, electrodes". These are physical hardware components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Neurotech Plus device is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Neurotech Plus Function: The Neurotech Plus device uses electrical stimulation (NMES and TENS) applied externally to the body for therapeutic purposes (pain relief, muscle re-education, etc.). It does not analyze any biological samples.
Intended Use: The stated intended uses are all related to physical therapy and pain management through external electrical stimulation.
Device Description: The description details a portable electrical stimulation unit with electrodes, not a device for analyzing biological samples.

Therefore, the Neurotech Plus device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended Use: Dependent on the program chosen, the Neurotech Plus, Type 413 can deliver Neuromuscular Electrical Stimulation (NMES) for the activation of muscle for rehabilitation and/or Transcutaneous Electrical Nerve Stimulation (TENS) for the activation of nerves for neuromodulation and management of pain.

Indications for Use:
Models 431, 432, 433, 434, 436, 439, & 440 offer a combination of NMES or TENS programs.

NMES Indications for Use
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

TENS Indications for Use
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain
Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432, 433 only)

Models 437, 441 (NMES only indications for use)
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

Model 438 (TENS only indications for use)
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain

Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.

Product codes (comma separated list FDA assigned to the subject device)

GZJ, NYN, IPF

Device Description

The Neurotech Plus is a portable, two-channel; battery operated system which can provide both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The device is intended be available by prescription only. Included with the Neurotech Plus control unit, are a lead wire assembly, electrodes and instructions for use.

The Neurotech Plus contains ten program sets which have been each allocated an individual type number. Seven of these types offer a combination of NMES and TENS programs. There are two types which offer only NMES programs and one which has only TENS programs.

The lead-wire assembly contains the ID chip (EEPROM) that identifies the required program set. Each of the program set options are pre-programmed during manufacturing and no access to the configuration is available to either the end user or clinician. When each lead wire is connected to the unit and the outputs (A, B, C or D) to the electrodes, the two channels may be operated independently through the unit. Detailed diagrams for correct device usage and placement of the electrodes are available as part of the instructions for use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082011, K061516, K971437

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for bio-medical research ltd. The logo consists of the letters "bmr" in a bold, sans-serif font. Below the letters is the text "bio-medical research ltd." in a smaller, sans-serif font. The letters "bmr" are connected by a thin, curved line.

K112258

This 510k Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

Name:	Anne-Marie Keenan
Address:	Bio-Medical Research Ltd.,
Parkmore Business Park, West
Galway, Ireland
Telephone:	+353 91 774300
Fax:	+353 91 774302
E-Mail:	akeenan@bmr.ie
Prepared:	November ,2, 2011

2. Device Name and Regulation

Trade Name of Device:	Neurotech Plus, Type 413
Regulation Number:	21 CFR 882.5890
Regulation Name	Transcutaneous electrical nerve stimulator for pain relief
Product Code:	GZJ, NYN, IPF
Device Class:	II

3. Identification of Equivalent Legally Marketed Device

510(k) Number:	K082011
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	MediStim XP, Type 281

1

510(k) Number:	K082011
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	MediTens XP, Type 458
510(k) Number:	K061516
Manufacturer:	Compex Technologies
Trade Name:	Staodyn® Max, Model 4470
510(k) Number:	K971437
Manufacturer:	Murray Electronics
Trade Name	Bionicare Stimulator System Model Bio-1000

4. Description of Device

The Neurotech Plus is a portable, two-channel; battery operated system which can provide both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The device is intended be available by prescription only. Included with the Neurotech Plus control unit, are a lead wire assembly, electrodes and instructions for use.

The Neurotech Plus contains ten program sets which have been each allocated an individual type number. Seven of these types offer a combination of NMES and TENS programs. There are two types which offer only NMES programs and one which has only TENS programs.

The lead-wire assembly contains the ID chip (EEPROM) that identifies the required program set. Each of the program set options are pre-programmed during manufacturing and no access to the configuration is available to either the end user or clinician. When each lead wire is connected to the unit and the outputs (A, B, C or D) to the electrodes, the two channels may be operated independently through the unit. Detailed diagrams for correct device usage and placement of the electrodes are available as part of the instructions for use.

5. Statement of Intended Use/Indications for Use

Intended Use: Dependent on the program chosen, the Neurotech Plus, Type 413 can deliver Neuromuscular Electrical Stimulation (NMES) for the activation of muscle for rehabilitation

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2

and/or Transcutaneous Electrical Nerve Stimulation (TENS) for the activation of nerves for neuromodulation and management of pain.

Indications for Use:

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i

Models 431, 432, 433, 434, 436, 439, & 440 offer a combination of NMES or TENS programs.

NMES Indications for Use

Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery

TENS Indications for Use

Symptomatic relief and management of chronic, intractable pain Relief of pain associated with arthritis Adjunctive treatment in the management of post-surgical and post-trauma pain Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432, 433 only)

Models 437, 441 (NMES only indications for use)

Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery

Model 438 (TENS only indications for use)

Symptomatic relief and management of chronic, intractable pain Relief of pain associated with arthritis Adjunctive treatment in the management of post-surgical and post-trauma pain

Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.

3

6. Summary of Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Neurotech Plus device. No new clinical tests have been submitted as part of this premarket notification.

The Neurotech Plus device complies with the following international standards:

IEC 60601-1 (1998) + A1 (1991) + A2 (1995) Medical Electrical Equipment Part 1: . General Requirements for Safety.
. IEC 60601-2-10 (1987) + A1 (2001) Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators.
IEC 60601-1-2:2001 Medical electrical equipment Part 1-2: General requirements . for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests :
I.S. EN ISO 14971 2007 .

6.1 Program Sets

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Tables 6.1.1 to 6.1.10 show the program parameters for each model of the Neurotech Plus.

4

| Table 6.1+.1
Model 431 | Screen
Text | Intensity | Rate
(Hz or pps) (usec) (sec.) | Relax
(sec.) | Ramp
Up
(sec.) | Ramp
Down
(sec.) | Additional Functions Time
(minutes) |
|---------------------------|--- | 1 | P1 modulates
(decreases) between
125 to 4 in 12
second cycle -
remains at 125 for 3
seconds and 4 for 3
seconds of cycle
time
(see Note 1) | 150 to 250;
modulates
(increases) between
150 to 250 in 12
second cycle -
remains at 150 for 3
seconds and 250 for
3 seconds of cycle
time
(see Note 1) | | 2 | P2 output remains constant button. Press Burst again up/down will be implemented | 3 | P3 Ch 2: 125 & Ch2 125 Hz, 200 usec. remains constant for 10 pressed. No ramp up/down (See note 2) | 4 | P4 remains constant while ramp up/down will be implemented | 5 | P5 | 6 | P6 | 7 | P7 | 8 | P8 | 9 | P9 | 10 | P10 70 200 10 |
| | 70 200 20 |
| | | Table 6.1.2
Model 432 | Screen
Text | Intensity | Rate
(Hz or pps) (usec) (sec.) | Relaxation
(sec.) | Ramp Up
(Sec.) | Ramp
Down
(Sec.) | Additional Functions (minutes) |
| 1 | P1 modulates (decreases)
between 125 to 4 in 12
second cycle - remains at
125 for 3 seconds and 4
for 3 seconds of cycle
time modulates (increases)
between 150 to 250 in
12 second cycle -
remains at 150 for 3
seconds and 250 for 3
seconds of cycle time Activation and output
remains constant
while pressing burst
button. No ramp
up/down will be
implemented | 2 | P2 | 3 | P3 Ch 2: 125 Burst - Ch1 125 Hz,
200 usec & Ch2 125
Hz, 200 usec.
Activation and output
remains constant for
10 minutes after burst
button pressed. No
ramp up/down will be
implemented.
(See note 2) | Open | 4 | P4 usec. Activation and
output remains
constant while
pressing burst button.
No ramp up/down will
be implemented | 5 | P5 | 6 | P6 | 7 | P7 | 8 | P8 | 9 | P9 | 10 | P10 100 200 | | 100 200 | Pulse Width
| Cont
| Treatment
-------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------|----------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Adj | 125 to 4;
| | | | | Open |
| Adj | 99 | 200 | | | | | Burst Toggle - 4 Hz, 250 usec Activation and
after pressing the burst
to cancel. No ramp
| Open |
| Adj | Ch 1: 4
| 200 | | | | | Criss-cross Function, Burst - Ch1 125 Hz, 200 usec
Activation and output
minutes after burst button
will be implemented
| Open |
| Adj | 4 | 250 | | | | | Burst - 125 Hz, 175 usec. Activation and output
pressing burst button. No
| Open |
| Adj | 50 | 300 | 5 | | 15 | 1.0 | | 30 |
| Adj | 50 | 300 | 5 | | 10 | 1.0 | Trigger | 30 |
| Adj | 50 | 300 | 5 | | 5 | 1.0 | Trigger | 30 |
| Adj | 35 | 300 | 5 | | 10 | 1.0 | Trigger | 30 |
| Adj | 8 | 300 | 5 | | 5 | 1.0 | Trigger | 20 |
| Adj | 100
| 100
| 5 | | 15 | 1.0 | | 90
| Adj | 100
| 100
| 5 | | 15 | 1.0 | | 90
| Adj | 100 | 100 | | | | | | 90 |
| Pulse Width
| Contract
| Treatment Time
| Adj | 125 to 4;
| 150 to 250;
| | | | | Burst-4Hz, 250 usec.
| Open |
| Adj | 99 | 200 | | | | | | Open |
| Adj | Ch 1: 4
| 200 | | | | | Criss-cross Function,
|
| Adj | 4 | 250 | | | | | Burst-125Hz, 175
| Open |
| Adj | 50 | 300 | 5 | 15 | 1.0 | 0.5 | Trigger | 30 |
| Adj | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| Adj | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| Adj | 35 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 20 |
| Adj | 8 | 300 | 5 | 5 | 1.0 | .5 | Trigger | 20 |
| Adj | 70
| 100
| 5 | 15 | 1.0 | 0.5 | | 70 |
| | 70
| 100
| 5 | 15 | 1.0 | 0.5 | | 70 |

.

Page 5 of 33

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Page 6 of 33

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6

| Table 6.1.3
Model 433 | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Contraction
(sec.) | Relaxation
(sec.) | Ramp Up
(Sec.) | Ramp
Down
(Sec.) | Additional
Functions | Treatment
Time
(minutes) |
|--------------------------|----------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------|----------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 1 | P1 | Adjustable | 125 to 4;
modulates
(decreases)
between 125 to
4 in 12 second
cycle - remains
at 125 for 3
seconds and 4
for 3 seconds of
cycle time | 150 to 250;
modulates
(increases)
between 150 to
250 in 12
second cycle -
remains at 150
for 3 seconds
and 250 for 3
seconds of
cycle time | | | | | | Open |
| 2 | P2 | Adjustable | 125 | 175 | | | | | | Open |
| 3 | P3 | Adjustable | 4 | 250 | | | | | Burst -
Frequency of 4
Hz, pulse width
of 250 usec.
Activation and
output remains
constant while
pressing burst
button. Will
ramp down over 3
sec. and up over 3
sec | Open |
| 4 | P4 | Adjustable | 50 | 300 | 5 | 15 | 1.0 | 0.5 | Trigger | 30 |
| 5 | P5 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 6 | P6 | Adjustable | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| 7 | P7 | Adjustable | 35 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adjustable | 8 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 20 |
| 9 | P9 | Adjustable | 100 | 100 | | 15 | 1.0 | 0.5 | Burst -
Frequency of 125
Hz. pulse width
of 175 usec.
Activation and
output remains
constant while
pressing burst
button. No ramp
upodwn will be
implemented. | 70 |
| 10 | P10 | Adjustable | 70 | 200 | 5 | 15 | 1.0 | 0.5 | Trigger | 20 |
| Table 6.1.4
Model 434 | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Contraction
(sec.) | Relaxation
(sec.) | Ramp
Up
(Sec.) | Ramp
Down
(Sec.) | Additional
Functions | Treatment
Time
(minutes) |
| 1 | P1 | Adjustable | 80 | 120 | Continuous
Stimulation | | 2 | | | Open |
| 2 | P2 | Adjustable | 2 | 180 | Continuous
Stimulation | | 2 | | | Open |
| 3 | P3 | Adjustable | 80 | 70-120 | Continuous
Stimulation | | 2 | | | Open |
| 4 | P4 | Adjustable | 80/2 | 180 | Continuous
Stimulation | | 2 | | | Open |
| 5 | P5 | Adjustable | 9/2 | 300 | Continuous
Stimulation | | 2 | | | 20 |
| 6 | P6 | Adjustable | 8 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 20 |
| 7 | P7 | Adjustable | 35 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adjustable | 50 | 300 | 5 | 15 | 1.0 | 0.5 | Trigger | 30 |
| 9 | P9 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 10 | P10 | Adjustable | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| Table 6.1.5
Model 436 | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Contraction
(sec.) | Relaxation
(sec.) | Ramp Up
(Sec.) | Ramp Down
(Sec.) | Additional Functions | Treatment
Time
(minutes) |
| 1 | P1 | Adjustable | 125 to 4:
modulates
(decreases)
between 125 to 4
in 12 second
cycle - remains at
125 for 3 seconds
and 4 for 3
seconds of cycle
time | 150 to 250;
modulates
(increases)
between 150 to
250 in 12 second
cycle - remains at
150 for 3 seconds
and 250 for 3
seconds of cycle
time | NA | NA | NA | NA | None | Open |
| 2 | P2 | Adjustable | 125 to 4;
modulates
(decreases)
between 125 to 4
in 12 second
cycle - remains at
125 for 3 seconds
and 4 for 3
seconds of cycle
time | 50 to 100;
modulates
(increases)
between 50 to 100
in 12 second cycle

remains at 50 for
3 seconds and 100
for 3 seconds of
cycle time | NA | NA | NA | NA | None | Open |
| 3 | P3 | Adjustable | 125 | 150 | NA | NA | NA | NA | Burst - Frequency is
80hz, pulse width 300
usec with 8 pulses per
burst;
2 bursts per second. 12
second cycle time - 2
seconds modulation
from normal to burst, 8
seconds at burst, 2
seconds modulating
from burst to normal.
Frequency will
increment/decrement
during the transition
to/from burst. | Open |
| 4 | P4 | Adjustable | 80 | 300 | 10 | 25
(Remove
Beep) | 1.5 | 1.5 | Trigger | 30 |
| 5 | P5 | Adjustable | 50 | 300 | 10 | 20 (Remove
Beep) | 1.5 | 1.5 | Trigger | 30 |
| 6 | P6 | Adjustable | 35 | 300 | 5 | 5 | 1.5 | 1.5 | Trigger | 30 |

·

Page 7 of 33

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Page 8 of 33

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Relax time	5 seconds	5 seconds	5 seconds	seconds
Ramp Down Time	2 seconds	2 seconds	2 seconds	2 seconds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Contract Time	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
seconds	3 seconds	ANNUAL ALL PROPERTY LA CONSULT LE LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LE
seconds	seconds
-----------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-
Ramp-Up time	2seconds	2seconds

                                                                                                                                                                     | And And Commend Commend Comments of Children

2seconds | 2seconds |
| A . A . A
Pulse Width | 2000 Js | Carles Market
225 Us | 2500s | 2700s |
| Carreland Contract
Frequency | 0Hz | 55Hz
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 55Hz
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A

50Hz
Duration
STERE COLORIO CONSULTION
A Land State State of States of Active Andrew
i
Table 6.1.6
Model 437
Particle Property of Children Comments of Children
11-2017 Com
Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children States of th

| Table 6.1.7
Model 438 | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Pulse | Treatment Time
(minutes) |
|--------------------------|----------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------|
| 1 | P1 | Adjustable | 125 to 4;
modulates (decreases) between 125 to 4 in 12 second cycle – remains at 125 for 3 seconds and 4 for 3 seconds of cycle time | 150 to 250;
modulates (increases) between
150 to 250 in 12 second cycle -
remains at 150 for 3 seconds and
250 for 3 seconds of cycle time | NA | 45 |
| 2 | P2 | Adjustable | 125 to 4;
modulates (decreases) between 125 to 4 in 12 second cycle – remains at 125 for 3 seconds and 4 for 3 seconds of cycle time | 50 to 100;
modulates (increases) between 50
to 100 in 12 second cycle -
remains at 50 for 3 seconds and
100 for 3 seconds of cycle time | NA | 45 |
| 3 | P3 | Adjustable | 125 | 175 | NA | 45 |
| 4 | P4 | Adjustable | 4 | 250 | NA | 45 |
| 5 | P5 | Adjustable | Channel 1 - 4
Channel 2 - 125 | 175 | NA | 45 |
| 6 | P6 | Adjustable | 80 | 175 | 8 pulses per burst;
2 bursts per second | 45 |
| 7 | P7 | Adjustable | 125 to 50;
modulates (decreases) between 125 and 50 in 8 second cycle (4/4) | 175 | NA | 45 |
| 8 | P8 | Adjustable | 125 | 250 to 150;
modulates (decreases) between
250 and 150 in 8 second cycle
(4/4) | NA | 45 |
| 9 | P9 | Adjustable | 125 to 50;
modulates (decreases) between 125 to 50 in 6 second cycle (3/3) | 50 to 100;
modulates (increases) between 50
to 100 in 6 second cycle (3/3) | NA | 45 |
| 10 | P10 | Adjustable | 125 to 50;
modulates (decreases) hetween 125 and 50 in 10 second cycle (5/5) | 150 to 250;
modulates (increases) between
150 and 250 in 10 second cycle
(5/5) | NA | 45 |

Page 10 of 33

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10

| Table 6.1.8
Model 439 | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Contraction
(sec.) | Relaxation
(sec.) | Ramp Up
(Sec.) | Ramp Down
(Sec.) | Additional
Functions | Treatment
Time
(minutes) |
|--------------------------|----------------|------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------|-------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 1 | P1 | Adjustable | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| 2 | P2 | Adjustable | 50 | 300 | 10 | 10 | 1.0 | 1.0 | Trigger | 30 |
| 3 | P3 | Adjustable | 50 | 300 | 10 | 20 | 1.5 | 1.0 | Trigger | 30 |
| 4 | P4 | Adjustable | 50 | 300 | 10 | 30 | 1.5 | 1.0 | Trigger | 30 |
| 5 | P5 | Adjustable | 35 | 250 | 8 | 25 | 1.5 | 1.0 | Trigger | 30 |
| 6 | P6 | Adjustable | 35 | 300 | 5 | 5 | 1.0 | 1.0 | Trigger | 30 |
| 7 | P7 | Adjustable | 10 | 250 | 10 | 10 | 1.5 | 1.0 | Trigger | 30 |
| 8 | P8 | Adjustable | 4 | 250 | | | | | Burst-125 Hz, 175 usec.
Activation and output remains constant while pressing burst button.
Will ramp up over 3 sec. and down over 3 sec | 45 |
| 9 | P9 | Adjustable | 125 | 175 | | | | | No-trigger | 45 |
| 10 | P10 | Adjustable | 125 to 4; modulates (decreases) between 125 to 4 in 12 second cycle - remains at 125 for 3 sec. and 4 for 3 sec. of cycle time | 150 to 250; modulates (increases) between 150 to 250 in 12 sec. cycle - remains at 150 for 3 sec. and 250 for 3 sec. of cycle time | | | | | No-trigger | 45 |

Page 11 of 33

·

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11

| Table 6.1.9
Model 440 | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Contraction
(sec.) | Relaxation
(sec.) | Ramp Up
(Sec.) | Ramp
Down
(Sec.) | Additional Functions | Treatment
Time
(minutes) |
|--------------------------|----------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------|----------------------|------------------------|--------------------------------------|--------------------------------|
| 1 | P1 | Adjustable | 125 to 4;
modulates
(decreases)
between 125 to 4
in 12 second cycle

remains at 125
for 3 seconds and
4 for 3 seconds of
cycle time | 150 to 250;
modulates
(increases)
between 150 to
250 in 12 second
cycle - remains at
150 for 3 seconds
and 250 for 3
seconds of cycle
time | | | | | | Open |
| 2 | P2 | Adjustable | 99 to 50;
modulates
(decreases)
between 99 and 50
in 8 second cycle
(4/4) | 150 to 250;
modulates
(increases)
between 150 to
250 in 8 second
cycle (4/4) | | | | | | Open |
| 3 | P3 | Adjustable | 125 | 175 | | | | | Criss-cross Function
(See note 3) | Open |
| 4 | P4 | Adjustable | 4 | 250 | | | 1.0 | | | |
| 5 | P5 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 6 | P6 | Adjustable | 50 | 300 | 10 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 7 | P7 | Adjustable | 50 | 300 | 10 | 20 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adjustable | 50 | 300 | 10 | 30 | 1.0 | 0.5 | Trigger | 30 |
| 9 | P8 | Adjustable | 35 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 20 |
| 10 | P10 | Adjustable | 10 | 300 | 10 | 10 | 1.0 | 0.5 | Trigger | 20 |
| | Screen
Text | Intensity | Rate
(Hz or pps) | Width
(usec) | Contraction
(sec.) | Relaxation
(sec.) | Ramp
Up
(Sec.) | Ramp
Down
(Sec.) | Additional
Functions | Treatment
Time
(minutes) |
| 5.1.10
441 | P1 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 20 |
| | P2 | Adjustable | 50 | 300 | 10 | 10 | 1.0 | 0.5 | Trigger | 20 |
| | P3 | Adjustable | 50 | 300 | 10 | 20 | 1.0 | 0.5 | Trigger | 20 |
| | P4 | Adjustable | 50 | 300 | 10 | 30 | 1.0 | 0.5 | Trigger | 20 |
| | P5 | Adjustable | 35 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 20 |
| | P6 | Adjustable | 4 | 300 | Continuous Stimulation | | | | No-Trigger | 20 |
| | P7 | Adjustable | 10 | 300 | 20 | 5 | 1.5 | 0.5 | Trigger | 20 |
| | P8 | Adjustable | 70 | 300 | 10 | 50 | 1.0 | 0.5 | Trigger | 20 |
| | P9 | Adjustable | 99 | 300 | 5 | 30 | 1.0 | 0.5 | trigger | 30 |

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Page 12 of 33

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Substantial Equivalence Comparison Tables 1

analysis carried out between the proposed Neurotech Plus and the proposed device is as safe, as effective and Each model of the Neurotech Plus, Type 413 device has been compared to it's predicate device at the worst case program. Based on comparati performs as well or better than the listed predicate

13

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| Table 7.1 | | Neurotech Plus
Model 431 | Predicate Device
Staodyn Max
K061516 | Predicate
Bionicare
K971437 | Predicate
MediTens
K082011 |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Mode or Program Name
(For calculation of maximum rms current, and power density) | | Plan 3 (Highest Output) | Program E (Highest output) | Only has 1 mode | Program 3
99Hz, 150μS |
| Waveform (e.g pulsed monophasic, biphasic) | | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic
Rectangular | Pulsed, Monophasic
Exponential, Spike | Pulsed, symmetric, biphasic |
| Shape (e.g rectangular, spike, rectified sinusoidal) | | Rectangular, with interphase interval | | | Rectangular, with interphase interval |
| Maximum Output Voltage (volts)(+/- 10%) | | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 30.0V @ 500 Ω
Not available
Not available | 12V 500Ω
Not available
Not available | 37.5V @ 500 Ω
70.0V@ 2 kΩ
71.8V @ 10 kΩ |
| Maximum Output Current (specify units)(+/- 10%) | | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0mA @ 10 kΩ | 60.0 mA @ 500 Ω
Not available
Not available | 24mA @ 500Ω
Not available
Not available | 75.0mA @ 500 Ω
35.0mA @ 500 Ω
7.0mA @ 10 kΩ |
| RMS Output Voltage (volts)(+/- 10%) | | 7.8V @ 500 Ω | 8.9V @ 500 Ω | 4.3V
Estimated assuming a square pulse shape 0.64ms | 6.5V@500Ω |
| | | 16.8V @ 2 kΩ
7.9V @ 10 kΩ | Not available
Not available | Not available
Not available | 14.2V@2kΩ
4.95V@10kΩ |
| RMS Output Current (specify units)(+/- 10%) | | 15.7mA @ 500 Ω | 17.8mA @ 500 Ω | 8.6mA | 13mA@500Ω |
| | | 8.4mA @ 2 kΩ
0.8mA @ 10 kΩ | Not available
Not available | Not available
Not available | 7.1mA@2kΩ
0.5mA@10kΩ |
| Duration of primary (depolarizing) phase (usec) | | 250uS | 60-350uS | 640 μδ | 150uS |
| Pulse Duration (usec) | | 400-600uS (uS both phases +
100µS interphase delay) | 700uS (350 uS both phases) | 640 με | 400μς |
| Frequency (Hz)[ or Rate (pps) ] | | 4 to 125Hz | 80 to 125 Hz | 100 Hz | 4 to 99 Hz |
| For multiphasic waveforms only: | Symmetrical phases? | Yes | Yes | N/A | Yes |
| | Phase duration (include | 100 to 250μ S | 60-350ut | N/A | 100 to 150uS |
| Table 7.1 | | Neurotech Plus
Model 431 | Predicate Device
Staodyn Max
K061516 | Predicate
Bionicare
K971437 | Predicate
MediTens
K082011 |
| | (units) state range, if
applicable)(both phases, if
asymmetrical) | | | | |
| | Net Charge(microcoulombs (uC) per pulse) (if zero,
state method of achieving zero net charge.) | 0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. | 0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. | 21 μC @ 500 Ω | 0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. |
| | Maximum Phase Charge (uC) | 10.5 to 17.5 μC @ 500 Ω | 9 to 21 μC @ 500 Ω | 21 μC @ 500 Ω | 7.5 to 11.25 μC @ 500 Ω |
| | Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the duration of averaging for
worst case (highest) output} | $0.80mA/cm^2(T=1sec)$ | Program E
Using 2" square electrode
=17.8 mA/25 cm²
= 0.71mA/cm² | $0.08 mA/cm^2$
i.e. 8.6mA/108 cm²
Using 12 x 9 cm electrodes | $0.672mA/cm^2$
5cm round electrode) |
| | Maximum Average Current (average absolute value),
mA { @ 500 Ω] | 3.5mA | 5.3mA | 2.1mA | 2.25mA |
| | Maximum Average Power Density, (W/ cm²), (using
smallest electrode conductive surface area)
{ @ 500 Ω Where T is the output duration} | 6.2mW (T=1sec)
50mm round electrode | $6.3 mW/cm^2$
Program E
Using 2" square electrode | $0.34 mW/cm^2$ | $4.4mW/cm^2$
50mm round electrode |
| | Burst Mode (i.e., pulse (a) Pulses per burst
trains): | N/A
Burst mode is simply an alternate
frequency-pulse witdh
combination. There are actually
no intermittent bursts | 8 | N/A | N/A
Burst mode is simply an alternate
frequency-pulse witdh
combination. There are actually
no intermittent bursts |
| | (b) Bursts per second | N/A | 2 | N/A | N/A |
| | (c) Burst duration
(seconds) | N/A | 0.09 | N/A | N/A |
| | (d) Duty Cycle ( Line (b) x
Line (c) ) | N/A | .18 | N/A | N/A |
| | ON Time (seconds) | N/A | N/A | N/A | N/A |
| | OFF Time (seconds) | N/A | N/A | N/A | N/A |

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| Table 7.2 | Mode or Program Name | Neurotech Plus
Model 432 | Predicate Device
Staodyn Max
K061516 | Predicate
Bionicare
K971437 | Predicate
MediTens
K082011
Program 3 (99Hz, 150μS) |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| | Waveform (e.g pulsed monophasic, biphasic) | Plan 3 | Program E (Highest output) | Only has 1 mode | |
| | Shape (e.g rectangular, spike, rectified sinusoidal) | Pulsed, symmetric, biphasic
Rectangular, with interphase interval | Pulsed, symmetric, biphasic
Rectangular | Pulsed, Monophasic
Exponential, Spike | Pulsed, symmetric, biphasic
Rectangular, with interphase interval |
| | Maximum Output Voltage (volts)(+/-10%) | 35.0V @ 500 Ω | 30.0V @ 500 Ω | 12V 500Ω | 37.5V @ 500 Ω |
| | | 75.0V @ 2 kΩ | Not available | Not available | 70.0V @ 2 kΩ |
| | | 70.3V @ 10 kΩ | Not available | Not available | 71.8V @ 10 kΩ |
| | Maximum Output Current (specify units)(+/-10%) | 70.0mA @ 500 Ω | 60.0 mA @ 500 Ω | 24mA @ 500Ω | 75.0mA @ 500 Ω |
| | | 37.5mA @ 2 kΩ | Not available | Not available | 35.0mA @ 500 Ω |
| | | 7.0mA @ 10 kΩ | Not available | Not available | 7.0mA @ 10 kΩ |
| | RMS Output Voltage (volts)(+/-10%) | 7.8V @ 500 Ω | 8.9V @ 500 Ω | 4.3V
Estimated assuming a square pulse
shape 0.64ms | 6.5V@500Ω |
| | | 16.8V @ 2 kΩ | Not available | Not available | 14.2V@2kΩ |
| | | 7.9V @ 10 kΩ | Not available | Not available | 4.95V@10kΩ |
| | RMS Output Current (specify units)(+/- 10%) | 15.7mA @ 500 Ω | 17.8mA @ 500 Ω | 8.6mA | 13mA@500Ω |
| | | 8.4mA @ 2 kΩ | Not available | Not available | 7.1mA@2kΩ |
| | | 0.8mA @ 10 kΩ | Not available | Not available | 0.5mA@10kΩ |
| | Duration of primary (depolarizing) phase (usec) | 150-250uS | 60-350uS | 640 μS | 150uS |
| | Pulse Duration (usec) | 400-600uS (uS both phases + 100μs interphase delay) | 700uS (350 uS both phases) | 640 μS | 400μS |
| | | | | | Both phases |
| | Frequency (Hz)[ or Rate (pps) ] | 4-125Hz | 80 to 125 Hz | 100 Hz | 4 to 99 Hz |
| | For multiphasic waveforms only: | Symmetrical phases? | N/A | No | Yes |
| | Phase duration (include units) state range, if | 60-350uS | N/A | | 100 to 150uS |
| Table 7.2 | | | | | |
| | Neurotech Plus
Model 432 | Predicate Device
Staodyn Max
K061516 | Predicate Bionicare
K971437 | Predicate MediTens
K082011 | |
| applicable)(both phases, asymmetrical) if
Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving zero net charge.) | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity alternates for each successive pulse. | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity alternates for each successive pulse. | 21 μC @ 500Ω | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity alternates for each successive pulse. | |
| Maximum Phase Charge (uC) | 14.0 μC @ 500 Ω | 9 to 21 μC @ 500 Ω | 21 μC @ 500Ω | 7.5 to 11.25 μC @ 500 Ω | |
| Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration} | 0.80mA/cm²(T=1sec) | Program E
Using 2" square electrode
=17.8 mA/25 cm²
= 0.71mA/cm² | 0.08 mA/cm²
i.e. 8.6mA/108 cm²
Using 12 x 9 cm electrodes | 0.672mA/cm²
5cm round electrode) | |
| Maximum Average Current (average absolute value), mA {@ 500 Ω} | 3.5mA | 5.3mA | 2.1mA | 2.25mA | |
| Maximum Average Power Density, (W/ cm²),
(using smallest electrode conductive surface area)
{@ 500 Ω Where T is the output duration} | 6.2mW (T=1sec) | 6.3 mW/cm²
Program E
Using 2" square electrode | 0.34 mW/cm² | 4.4mW/ cm²
50mm round electrode | |
| Burst Mode (i.e., pulse trains): | Burst mode is simply an alternate frequency-pulse witdh combination.
There are actually no intermittent bursts | 8 | N/A | Burst mode is simply an alternate frequency-pulse witdh combination. There are actually no intermittent bursts | |
| (a) Pulses per burst | N/A | | | | |
| (b) Bursts per second | N/A | 2 | N/A | N/A | |
| (c) Burst duration (seconds) | N/A | 0.09 | N/A | N/A | |
| (d) Duty Cycle [
Line (b) x Line (c)] | N/A | .18 | N/A | N/A | |
| ON Time (seconds) | N/A | N/A | N/A | N/A | |
| OFF Time (seconds) | N/A | N/A | N/A | N/A | |
| Additional Features (specify, if applicable) | N/A | N/A | N/A | N/A | |

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| Table 7.3 | Mode or Program Name | Waveform (e.g pulsed monophasic, biphasic)
Shape (e.g rectangular, spike, rectified sinusoidal) | Maximum Output Voltage (volts)
(+/- 10%) | Maximum Output Current (specify units)
(+/- 10%) | RMS Output Voltage (volts)(+/- 10%) | RMS Output Current (specify units)(+/- 10%) | Duration of primary (depolarizing) phase (usec) | Pulse Duration (usec) | Frequency (Hz)[ or Rate (pps) ] | Symmetrical phases? | For multiphasic waveforms only:
Phase duration (include units) state range, if |
|--------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------|--------------------------------------------------|-------------------------------------------------|--------------------------------------------------------|---------------------------------|---------------------|-----------------------------------------------------------------------------------|
| Neurotech Plus
Model 433 | Plan 2 | Pulsed, symmetric, biphasic
Rectangular, with interphase interval | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0mA @ 10 kΩ | 7.3V @ 500 Ω | 14.6mA @ 500 Ω
7.8mA @ 2 kΩ
0.8mA @ 10 kΩ | 150-250uS | 400-600uS (uS both phases +
100µS interphase delay) | 4-125Hz | Yes | 60-350uS |
| Predicate Device
Staodyn Max
K061516 | Program E (Highest output) | Pulsed, symmetric, biphasic
Rectangular | 30.0V @ 500 Ω
Not available
Not available | 60.0 mA @ 500 Ω
Not available
Not available | 8.9V @ 500 Ω | 17.8mA @ 500 Ω
Not available
Not available | Not available | 700uS (350 uS both phases) | 80 to 125 Hz | Yes | N/A |
| Predicate
Bionicare
K971437 | Only has 1 mode | Pulsed, Monophasic
Exponential, Spike | 12V 500Ω
Not available
Not available | 24mA @ 500Ω
Not available
Not available | 4.3V
Estimated assuming a square pulse shape 0.64ms | 8.6mA
Not available
Not available | Not available | 640 µS | 100 Hz | | |
| Predicate
MediTens
K082011 | Program 3
99Hz, 150μS | Pulsed, symmetric, biphasic
Rectangular, with interphase interval | 37.5V @ 500 Ω
70.0V@ 2 kΩ
71.8V @ 10 kΩ | 75.0mA @ 500 Ω
35.0mA @ 500 Ω
7.0mA @ 10 kΩ | 6.5V@500Ω | Not available
14.2V@2kΩ
4.95V@10kΩ | Not available | 150uS
400μ S | Both phases
4 to 99 Hz | Yes | 100 to 150uS |

Page 18 of 33

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| Table 7.3 | | Neurotech Plus
Model 433 | Predicate Device
Staodyn Max
K061516 | Predicate
Bionicare
K971437 | Predicate
MediTens
K082011 |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | applicable)(both phases,
if asymmetrical) | | | | |
| | Net Charge(microcoulombs (uC) per pulse) (if zero,
state method of achieving zero net charge.) | 0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. | 0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. | 21 μC @ 500Ω | 0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. |
| | Maximum Phase Charge (uC) | 12.3 µC @ 500 Ω | 9 to 21 μC @ 500 Ω | 21 µC @ 500Ω | 7.5 to 11.25 µC @ 500 Ω |
| | Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration) | 0.75mA/cm²(T=1sec) | Program E
Using 2" square electrode
=17.8 mA/25 cm²
= 0.71mA/cm² | 0.08 mA/cm²
i.e. 8.6mA/108 cm²
Using 12 x 9 cm electrodes | 0.672mA/cm²
5cm round electrode) |
| | Maximum Average Current (average absolute value),
mA {@ 500 Ω) | 3.06mA | 5.3mA | 2.1mA | 2.25mA |
| | Maximum Average Power Density, (W/ cm²), (using
smallest electrode conductive surface area)
1 @ 500 Ω Where T is the output duration} | 5.5mW (T=1sec) | 6.3 mW/cm²
Program E
Using 2" square electrode | 0.34 mW/cm² | 4.4mW/cm²
50mm round electrode |
| | Burst Mode (i.e., pulse (a) Pulses per burst
trains): | N/A
Burst mode is simply an alternate
frequency-pulse witdh combination.
There are actually no intermittent
bursts | 8 | N/A | N/A
Burst mode is simply an alternate
frequency-pulse witdh
combination. There are actually
no intermittent bursts |
| | (b) Bursts per second | N/A | 2 | N/A | N/A |
| | (c) Burst duration
(seconds) | N/A | 0.09 | N/A | N/A |
| | (d) Duty Cycle [ Line
(b) x Line (c)] | N/A | .18 | N/A | N/A |
| | ON Time (seconds) | N/A | N/A | N/A | N/A |
| | OFF Time (seconds) | N/A | N/A | N/A | N/A |
| | Additional Features (specify, if applicable) | N/A | N/A | N/A | N/A |

Page 19 of 33

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| Table 7.4 | Mode or Program Name | Waveform (e.g pulsed monophasic, biphasic) | Shape (e.g rectangular, spike, rectified sinusoidal) | Maximum Output Voltage (volts)
(+/- 10%) | Maximum Output Current (specify units)
(+/- 10%) | RMS Output Voltage (volts)
(+/- 10%) | RMS Output Current (specify units)
(+/- 10%) | Duration of primary (depolarizing) phase (usec) | Pulse Duration (usec) | Frequency (Hz) or Rate (pps) ]
For multiphasic waveforms only: | Symmetrical phases? | Phase duration (include units) state range, if applicable)(both phases, if asymmetrical) | Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving zero net charge.) | | | | | | | | | |
|-----------|--------------------------------------------|--------------------------------------------|------------------------------------------------------|---------------------------------------------|-----------------------------------------------------|-----------------------------------------|-------------------------------------------------|-------------------------------------------------|-----------------------|-------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------|---------------|---------------|-----------|-----------------------------------------------------|--------------|-----|---------------|----------------------------------------------------------|
| | Neurotech Plus
Model 434 | Plan 4 | Pulsed, symmetric, biphasic | Rectangular, with interphase interval | 35.0V @ 500 Ω | 75.0V @ 2 ΚΩ | 70.3V @ 10 ΚΩ | 70.0mA @ 500 Ω | 37.5mA @ 2 ΚΩ | 7.0mA @ 10 ΚΩ | 5.4V @ 500 Ω | 11.6V @ 2 ΚΩ | 6.3V @ 10 ΚΩ | 10.8mA @ 500 Ω | 5.8mA @ 2 ΚΩ | 0.6mA @ 10 ΚΩ | 120-180uS | 340-460uS (uS both phases + 100μS interphase delay) | 2-80Hz | Yes | 100 to 250μ S | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity |
| | Predicate Device
Staodyn Max
K061516 | Program E (Highest output) | Pulsed, symmetric, biphasic | Rectangular | 30.0V @ 500 Ω | Not available | Not available | 60.0 mA @ 500 Ω | Not available | Not available | 8.9V @ 500 Ω | Not available | Not available | 17.8mA @ 500 Ω | Not available | Not available | 60-350uS | 700uS (350 uS both phases) | 80 to 125 Hz | Yes | 60-350uS | 0 μC @ 500 Ω
Symmetric, biphasic and |
| | Predicate Device
MediTens
K082011 | Program 3 (99Hz, 150µS) | Pulsed, symmetric, biphasic | Rectangular, with interphase interval | 37.5V @ 500 Ω | 70.0V @ 2 ΚΩ | 71.8V @ 10 ΚΩ | 75.0mA @ 500 Ω | 35.0mA @ 500 Ω | 7.0mA @ 10 ΚΩ | 6.5V@500Ω | 14.2V@2kΩ | 4.95V@10kΩ | 13mA@500Ω | 7.1mA@2kΩ | 0.5mA@10ΚΩ | 150uS | 400μ S | 4 to 99 Hz | Yes | 100 to 150uS | Ο μC @ 500 Ω
Symmetric, biphasic and leading |

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		alternates for each successive pulse.	leading polarity alternates for each successive pulse.	polarity alternates for each successive pulse.
Maximum Phase Charge (µC)		10.5µC @ 500 Ω	9 to 21 µC @ 500 Ω	7.5 to 11.25 µC @ 500 Ω
Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration}		0.55mA/cm²(T=1sec)	Program E
Using 2" square electrode
=17.8 mA/25 cm²
= 0.71mA/cm²	0.672mA/cm²
5cm round electrode)
Maximum Average Current (average absolute value), mA
{ @ 500 Ω}		1.68mA	5.3mA	2.25mA
Maximum Average Power Density, (W/ cm²), (using smallest electrode conductive surface area)
{@ 500 Ω Where T is the output duration}		3.0mW (T=1sec)	6.3 mW/cm²
Program E
Using 2" square electrode	4.4mW/ cm²
50mm round electrode
Burst Mode (i.e., pulse trains):	(a) Pulses per burst	N/A
Burst mode is simply an alternate
frequency-pulse witdh combination. There
are actually no intermittent bursts	8	N/A
Burst mode is simply an alternate
frequency-pulse witdh combination.
There are actually no intermittent
bursts
	(b) Bursts per second		2
	(c) Burst duration
(seconds)		0.09
	(d) Duty Cycle [ Line (b) x Line (c) ]		.18
ON Time (seconds)		N/A	N/A	N/A
OFF Time (seconds)		N/A	N/A	N/A
Additional Features (specify, if applicable)		N/A	N/A	N/A

:

Page 21 of 33

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21

| Table 7.5 | | Neurotech Plus
Model 436 | Predicate Device
Staodyn Max
K061516 | Neurotech Plus
Model 436 | Predicate Device
MediStim XP
K082011 |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| Mode or Program Name | | Plan 3 (TENS) | | Plan 4 (NMES) | |
| Waveform (e.g pulsed monophasic, biphasic) | | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic |
| Shape (e.g rectangular, spike, rectified sinusoidal) | | Rectangular, with interphase interval | Rectangular | Rectangular, with interphase interval | Rectangular, with interphase interval |
| Maximum Output Voltage (volts)(+/- 10%) | | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 30.0V @ 500 Ω
Not available
Not available | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 37.5V @ 500 Ω
70.0V@ 2 kΩ
71.8V @ 10 kΩ |
| Maximum Output Current (specify units)(+/- 10%) | | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0mA @ 10 kΩ | 60.0 mA @ 500 Ω
Not available
Not available | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0mA @ 10 kΩ | 75.0mA @ 500 Ω
35.0mA @ 500 Ω
7.0mA @ 10 kΩ |
| RMS Output Voltage (volts)(+/- 10%) | | 6.8V @ 500 Ω
14.5V @ 2 kΩ
7.8V @ 10 kΩ | Not available
Not available
Not available | 7.7V @ 500 Ω
16.4V @ 2 kΩ
6.3V @ 10 kΩ | 6.5 V @ 500 Ω
12.1V @ 2 kΩ
7.1V @ 10 kΩ |
| RMS Output Current (specify units)(+/- 10%) | | 13.6mA @ 500 Ω
7.3mA @ 2 kΩ
0.8mA @ 10 kΩ | Not available
Not available
Not available | 15.3mA @ 500 Ω
8.2mA @ 2 kΩ
0.6mA @ 10 kΩ | 13.0mA @ 500 Ω
6.0mA @2 kΩ
0.7mA @ 10 kΩ |
| Duration of primary (depolarizing) phase (usec) | | 50-250uS | 60-350uS | 300uS | 150-300uS |
| Pulse Duration (usec) | | 200-600uS (uS both
phases + 100μς
interphase delay) | 700uS (350 uS both
phases) | 600 uS (100 uS both
phases + 100μς
interphase delay) | 400-700us (100 uS both
phases + 100μ S
interphase delay) |
| Frequency (Hz)[ or Rate (pps) ] | | 4-125Hz | Not available | 35-80Hz | 2-100Hz |
| For multiphasic waveforms only: | Symmetrical phases?
Phase duration (include units) state
range, if applicable)(both phases, if
asymmetrical) | N/A | N/A | N/A | N/A |
| | Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving
zero net charge.) | 0 μC @ 500 Ω
Symmetric, biphasic and
leading polarity alternates | 0 μC @ 500 Ω
Symmetric, biphasic and
leading polarity alternates | 0 μC @ 500 Ω
Symmetric, biphasic and
leading polarity alternates | 0 μC @ 500 Ω
Symmetric, biphasic and
leading polarity alternates |
| Table 7.5 | | Neurotech Plus
Model 436 | Predicate Device
Staodyn Max
K061516 | Neurotech Plus
Model 436 | Predicate Device
MediStim XP
K082011 |
| | | for each successive pulse. | for each successive pulse. | for each successive pulse. | for each successive pulse. |
| Maximum Phase Charge (uC) | | $10.5µC @ 500 Ω$ | Not available | $21.0µC @ 500 Ω$ | $21.0µC @ 500 Ω$ |
| Maximum Current Density (mA/cm², r.m.s)
{ @ 500 Ω Where T is the output duration} | | $0.69mA/cm²(T=1sec)$ | Not available | $0.78mA/cm²(T=1sec)$ | $mA/cm²(T=1sec)$ |
| Maximum Average Current (average absolute value), mA { @ 500 Ω} | | 2.63mA | Not available | 3.36mA | Not available |
| Maximum Average Power Density, (W/ cm²), (using smallest electrode
conductive surface area)
{ @ 500 Ω Where T is the output duration} | | $4.7mW (T=1sec)$ | Not available | $6.0mW (T=1sec)$ | Not available |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst | N/A | N/A | N/A | N/A |
| | (b) Bursts per second | N/A | N/A | N/A | N/A |
| | (c) Burst duration (seconds) | N/A | N/A | N/A | N/A |
| | (d) Duty Cycle [Line (b) x Line (c) ] | N/A | N/A | N/A | N/A |
| ON Time (seconds) | | N/A | N/A | N/A | N/A |
| OFF Time (seconds) | | N/A | N/A | N/A | N/A |

Page 22 of 33

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| Table 7.6 | | Neurotech Plus
Model 437 | Predicate Device
MediStim XP
K082011 |
|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Mode or Program Name | | Plan 3 (NMES) | |
| Waveform (e.g pulsed monophasic, biphasic) | | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic |
| Shape (e.g rectangular, spike, rectified sinusoidal)- | | Rectangular, with interphase interval | Rectangular, with interphase interval |
| Maximum Output Voltage (volts)(+/- 10%) | | 35.0V @ 500 Ω | 37.5V @ 500 Ω |
| | | 75.0V @ 2 ΚΩ | 70.0V @ 2 ΚΩ |
| | | 70.3V @ 10 ΚΩ | 71.8V @ 10 ΚΩ |
| Maximum Output Current (specify units)(+/- 10%) | | 70.0mA @ 500 Ω | 75.0mA @ 500 Ω |
| | | 37.5mA @ 2 ΚΩ | 35.0mA @ 500 Ω |
| | | 7.0 mA @ 10 ΚΩ | 7.0mA @ 10 ΚΩ |
| RMS Output Voltage (volts)(+/-10%) | | 5.8V @ 500 Ω | 6.5 V @ 500 Ω |
| | | 12.4V @ 2 ΚΩ | 12.1V @ 2 ΚΩ |
| | | 5.2V @ 10 ΚΩ | 7.1V @ 10 ΚΩ |
| RMS Output Current (specify units)(+/- 10%) | | 11.6mA @ 500 Ω | 13.0mA @ 500 Ω |
| | | 6.2mA @ 2 ΚΩ | 6.0mA @ 2 ΚΩ |
| | | 0.5mA @ 10 ΚΩ | 0.7mA @ 10 ΚΩ |
| Duration of primary (depolarizing) phase (usec) | | 200-270uS | 150-300uS |
| Pulse Duration (usec) | | 500-640 uS (100 uS both phases + 100µS
interphase delay) | 400-700us (100 uS both phases + 100μS
interphase delay) |
| Frequency (Hz)[ or Rate (pps) ] | | 50-60Hz | 2-100Hz |
| For multiphasic waveforms only: | Symmetrical phases? | N/A | N/A |
| | Phase duration (include units) state
range, if applicable)(both phases, if
asymmetrical) | N/A | N/A |
| Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving
zero net charge.) | | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity alternates
for each successive pulse. | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity
alternates for each successive pulse. |
| Maximum Phase Charge (uC) | | 17.5μC @ 500 Ω | 21.0µC @ 500 Ω |
| Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration) | | 0.59mA/cm²(T=1sec) | |
| Table 7.6 | | Neurotech Plus
Model 437 | Predicate Device
MediStim XP
K082011 |
| Maximum Average Current (average absolute value), mA {@ 500 Ω} | | 1.93mA | Not available |
| Maximum Average Power Density, (W/ cm2), (using smallest electrode
conductive surface area) { @ 500 Ω Where T is the output duration} | | 3.4mW (T=1sec) | Not available |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst | N/A | N/A |
| | (b) Bursts per second | N/A | N/A |
| | (c) Burst duration (seconds) | N/A | N/A |
| | (d) Duty Cycle [ Line (b) x Line (c) ] | N/A | N/A |
| ON Time (seconds) | | N/A | N/A |
| OFF Time (seconds) | | N/A | N/A |
| Table 7.7 | | Neurotech Plus
Model 438 | Predicate Device
Staodyn Max
K061516 |
| Code or Program Name | | Plan 8 | |
| Waveform (e.g pulsed monophasic, biphasic) | | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic |
| Shape (e.g rectangular, spike, rectified sinusoidal) | | Rectangular, with interphase interval | Rectangular |
| Maximum Output Voltage (volts)(+/- 10%) | | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 30.0V @ 500 Ω
Not available
Not available |
| Maximum Output Current (specify units)(+/- 10%) | | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0mA @ 10 kΩ | 60.0 mA @ 500 Ω
Not available
Not available |
| RMS Output Voltage (volts)(+/- 10%) | | 8.7V @ 500 Ω
18.7V @ 2 kΩ
7.8V @ 10 kΩ | Not available
Not available
Not available |
| RMS Output Current (specify units)(+/- 10%) | | 17.5mA @ 500 Ω
9.4mA @ 2 kΩ
0.8mA @ 10 kΩ | Not available
Not available
Not available |
| Duration of primary (depolarizing) phase (usec) | | 50-250uS | 60-350uS |
| Pulse Duration (usec) | | 200-600uS (uS both phases + 100μS interphase delay) | 700uS (350 uS both phases) |
| Frequency (Hz)[ or Rate (pps) ]
for multiphasic waveforms only: | | 4-125Hz | N/A |
| Symmetrical phases? | | N/A | N/A |
| Phase duration (include units) state range, if applicable)(both phases, if asymmetrical) | | N/A | N/A |
| Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving zero net charge.) | | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity alternates for each successive pulse. | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity alternates for each successive pulse. |
| Maximum Phase Charge (uC) | | 17.5µC @ 500 Ω | |
| Maximum Current Density (mA/cm².r.m.s) | | 0.89mA/cm²(T=1sec) | |
| | Ω Where T is the output duration} | | |
| | Average Current (average absolute value), mA { @ 500 Ω} | 4.38mA | N/A |
| | Average Power Density, (W/ cm²), (using smallest electrode surface area) | 7.8mW (T=1sec) | N/A |
| | Ω Where T is the output duration} | | |
| | (i.e., pulse trains): | | |
| | (a) Pulses per burst | | N/A |
| | (b) Bursts per second | | N/A |
| | (c) Burst duration (seconds) | | N/A |
| | (d) Duty Cycle [ Line (b) x Line (c) ] | | N/A |
| | e (seconds) | | N/A |
| | ne (seconds) | | N/A |

24

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| Table 7.8 | | Neurotech Plus
Model 439 | Predicate Device
Staodyn Max
K061516 | Predicate
MediTens
K082011 |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Mode or Program Name | | Plan 9 (TENS) | Program E (Highest output) | Program 3 |
| | | | | 99Hz, 150µS |
| Waveform (e.g pulsed monophasic, biphasic) | | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic |
| Shape (e.g rectangular, spike, rectified sinusoidal) | | Rectangular, with interphase
interval | Rectangular | Rectangular, with interphase
interval |
| Maximum Output Voltage (volts)
(+/- 10%) | | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 30.0V @ 500 Ω
Not available
Not available | 37.5V @ 500 Ω
70.0V @ 2 kΩ
71.8V @ 10 kΩ |
| Maximum Output Current (specify units)
(+/- 10%) | | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0mA @ 10 kΩ | 60.0 mA @ 500 Ω
Not available
Not available | 75.0mA @ 500 Ω
35.0mA @ 500 Ω
7.0mA @ 10 kΩ |
| RMS Output Voltage (volts)
(+/- 10%) | | 6.8V @ 500 Ω
14.6V @ 2 kΩ
7.8V @ 10 kΩ | 8.9V @ 500 Ω
Not available
Not available | 6.5V @500Ω
14.2V @2kΩ
4.95V@10kΩ |
| RMS Output Current (specify units)
(+/- 10%) | | 13.6mA @ 500 Ω
7.3mA @ 2 kΩ
0.8mA @ 10 kΩ | 17.8mA @ 500 Ω
Not available
Not available | 13mA@500Ω
7.1mA@2kΩ
0.5mA@10kΩ |
| Duration of primary (depolarizing) phase (usec) | | 150-250uS | 60-350uS | 150uS |
| Pulse Duration
(usec) | | 400-600uS (uS both phases +
100µS interphase delay) | 700uS (350 uS both phases) | 400µS
Both phases |
| Frequency (Hz) [ or Rate (pps) ]
For multiphasic waveforms
only: | | 4-125Hz | 80 to 125 Hz | 4 to 99 Hz |
| Symmetrical Phases?
Phase Duration | | Yes
100 to 250µS | Yes
60-350uS | Yes
100 to 150uS |
| Net Charge(microcoulombs (uC) per pulse) (if zero, state method of
achieving zero net charge.) | | 0 µC @ 500 Ω
Symmetric, biphasic and
leading polarity alternates for
each successive pulse. | 0 µC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each
successive pulse. | 0 µC @ 500 Ω
Symmetric, biphasic and
leading polarity alternates for
each successive pulse. |
| Maximum Phase Charge (uC) | | 10.6μC @ 500 Ω | 9 to 21 µC @ 500 Ω | 7.5 to 11.25 μC @ 500 Ω |
| Table 7.8 | | Neurotech Plus
Model 439 | Predicate Device
Staodyn Max
K061516 | Predicate
MediTens
K082011 |
| Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration) | | 0.70mA/cm²(T=1sec) | Program E
Using 2" square electrode
=17.8 mA/25 cm²
= 0.71mA/cm² | 0.672mA/cm²
5cm round electrode) |
| Maximum Average Current (average absolute value),
mA (@ 500 Ω) | | 2.66mA | 5.3mA | 2.25mA |
| Maximum Average Power Density, (W/ cm²), (using smallest electrode
conductive surface area) {@ 500 Ω Where T is the output duration} | | 4.7mW (T=1sec) | 6.3 mW/cm²
Program E
Using 2" square electrode | 4.4mW/cm²
50mm round electrode |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst | N/A
Burst mode is simply an
alternate frequency-pulse width
combination. There are actually
no intermittent bursts | 8 | N/A
Burst mode is simply an
alternate frequency-pulse width
combination. There are actually
no intermittent bursts |
| | (b) Bursts per second | | 2 | |
| | (c) Burst duration (seconds) | | 0.09 | |
| | (d) Duty Cycle [ Line (b) x Line (c) ] | | .18 | |
| ON Time (seconds) | | N/A | N/A | N/A |
| OFF Time (seconds) | | N/A | N/A | N/A |
| Additional Features (specify, if applicable) | | N/A | N/A | N/A |
| Table 7.9 | | | | |
| | Neurotech Plus
Model 440 | Predicate Device
Staodyn Max
K061516 | Predicate
MediTens
K082011 | |
| Mode or Program Name | Plan 9 (TENS) | Program E (Highest output) | Program 3 (99Hz, 150μS) | |
| Waveform (e.g pulsed monophasic, biphasic) | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | |
| Shape (e.g rectangular, spike, rectified sinusoidal) | Rectangular, with interphase interval | Rectangular | Rectangular, with interphase interval | |
| Maximum Output Voltage (volts)(+/-10%) | 35.0V @ 500 Ω | 30.0V @ 500 Ω | 37.5V @ 500 Ω | |
| | 75.0V @ 2 ΚΩ | Not available | 70.0V @ 2 ΚΩ | |
| | 70.3V @ 10 ΚΩ | Not available | 71.8V @ 10 ΚΩ | |
| Maximum Output Current (specify units) (+/- 10%) | 70.0mA @ 500 Ω | 60.0 mA @ 500 Ω | 75.0mA @ 500 Ω | |
| | 37.5mA @ 2 ΚΩ | Not available | 35.0mA @ 500 Ω | |
| | 7.0mA @ 10 ΚΩ | Not available | 7.0mA @ 10 ΚΩ | |
| RMS Output Voltage (volts)(+/-10%) | 6.8V @ 500 Ω | 8.9V @ 500 Ω | 6.5V@500Ω | |
| | 14.6V @ 2 ΚΩ | Not available | 14.2V@2ΚΩ | |
| | 7.8V @ 10 ΚΩ | Not available | 4.95V@10ΚΩ | |
| RMS Output Current (specify units)(+/- 10%) | 13.6mA @ 500 Ω | 17.8mA @ 500 Ω | 13mA@500Ω | |
| | 7.3mA @ 2 ΚΩ | Not available | 7.1mA@2kΩ | |
| | 0.8mA @ 10 ΚΩ | Not available | 0.5mA@10ΚΩ | |
| Duration of primary (depolarizing) phase (usec) | 150-250uS | 60-350uS | 150uS | |
| Pulse Duration (usec) | 400-600uS (uS both phases + 100μδ
interphase delay) | 700uS (350 uS both phases) | 400μS | |
| Frequency (Hz)[ or Rate (pps) ] | 4-125Hz | 80 to 125 Hz | 4 to 99 Hz | |
| For multiphasic waveforms
only: | N/A | Yes | Yes | |
| Net Charge(microcoulombs (uC) per pulse)
(if zero, state method of achieving zero net charge.) | 100 to 250μς
0 μC @ 500 Ω
Symmetric, biphasic and leading polarity
alternates for each successive pulse. | 60-350uS
0 μC @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each successive
pulse | 100 to 150uS
0 μ€ @ 500 Ω
Symmetric, biphasic and leading
polarity alternates for each successive
pulse. | |
| Maximum Phase Charge (uC) | 10.6μC @ 500 Ω | 9 to 21 μC @ 500 Ω | 7.5 to 11.25 µε @ 500 Ω | |
| Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration} | 0.70mA/cm²(T=1sec) | Program E
Using 2" square electrode
=17.8 mA/25 cm² | 0.672mA/cm²
5cm round electrode) | |
| Table 7.9 | | Neurotech Plus
Model 440 | Predicate Device
Staodyn Max
K061516 | Predicate
MediTens
K082011 |
| Maximum Average Current (average absolute value),
mA { @ 500 Ω} | | 2.66mA | = 0.71mA/cm²
5.3mA | 2.25mA |
| Maximum Average Power Density. (W/ cm²), (using smallest
electrode conductive surface area)
{ @ 500 Ω Where T is the output duration) | | 4.7mW (T=1sec) | 6.3 mW/cm²
Program E
Using 2" square electrode | 4.4mW/cm²
50mm round electrode |
| Burst Mode (i.e.. pulse trains): | (a) Pulses per burst | N/A | 8 | N/A |
| | | Burst mode is simply an alternate
frequency-pulse witdh combination.
There are actually no intermittent bursts | | Burst mode is simply an alternate
frequency-pulse witdh combination.
There are actually no intermittent bursts |
| | (b) Bursts per second | | 2 | |
| | (c) Burst duration (seconds) | | 0.09 | |
| | (d) Duty Cycle
[ Line (b) x Line (c)] | | .18 | |
| ON Time (seconds) | | N/A | N/A | N/A |
| OFF Time (seconds) | | N/A | N/A | N/A |
| Additional Features (specify, if applicable) | | N/A | N/A | N/A |
| Table 7.10 | | | | |
| | | Neurotech Plus
Model 441 | Predicate Device
MediStim XP
K082011 | |
| Mode or Program Name | | Plan 9 (NMES) | | |
| Waveform (e.g pulsed monophasic, biphasic) | | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | |
| Shape (e.g rectangular, spike, rectified sinusoidal) | | Rectangular, with interphase interval | Rectangular, with interphase interval | |
| Maximum Output Voltage (volts)
(+/-10%) | | 35.0V @ 500 Ω
75.0V @ 2 kΩ
70.3V @ 10 kΩ | 37.5V @ 500 Ω
70.0V@ 2 kΩ
71.8V @ 10 kΩ | |
| Maximum Output Current (specify units)
(+/-10%) | | 70.0mA @ 500 Ω
37.5mA @ 2 kΩ
7.0 mA @ 10 kΩ | 75.0mA @ 500 Ω
35.0mA @ 500 Ω
7.0mA @ 10 kΩ | |
| RMS Output Voltage (volts)
(+/-10%) | | 8.5V @ 500 Ω
18.3V @ 2 kΩ
7.0V @ 10 kΩ | 6.5 V @ 500 Ω
12.1V @ 2 kΩ
7.1V @ 10 kΩ | |
| RMS Output Current (specify units)(+/- 10%) | | 17.1mA @ 500 Ω
9.1mA @ 2 kΩ
0.7mA @ 10 kΩ | 13.0mA @ 500 Ω
6.0mA @ 2 kΩ
0.7mA @ 10 kΩ | |
| Duration of primary (depolarizing) phase (usec) | | 300uS | 150-300uS | |
| Pulse Duration (usec) | | 400uS (100 uS both phases + 100μS
interphase delay) | 400-700us (100 us both phases + 100µS
interphase delay) | |
| Frequency (Hz) [ or Rate (pps) ] | | 10-99Hz | 2-100Hz | |
| For multiphasic waveforms only: | Symmetrical phases? | N/A | N/A | |
| | Phase duration (include units) state
range, if applicable)(both phases, if
asymmetrical) | N/A | N/A | |
| | Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving
zero net charge.) | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity
alternates for each successive pulse. | 0 μC @ 500 Ω
Symmetric, biphasic and leading polarity
alternates for each successive pulse. | |
| | Maximum Phase Charge (uC) | 21.0μC @ 500 Ω | 21.0µC @ 500 Ω | |
| Maximum Current Density (mA/cm², r.m.s)
{@ 500 Ω Where T is the output duration) | Maximum Average Current (average absolute value), mA {@ 500 Ω) | Maximum Average Power Density, (W/ cm² ), (using smallest electrode conductive surface area)
@ 500 Ω Where T is the output duration) | | |
| 0.87mA/cm²(T=1sec) | 4.16mA | 7.4mW (T=1sec) | Not available | |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst | N/A | N/A | |
| | (b) Bursts per second | N/A | N/A | |
| | (c) Burst duration (seconds) | N/A | N/A | |
| | (d) Duty Cycle [Line (b) x Line (c)] | N/A | N/A | |
| ON Time (seconds) | | N/A | N/A | |
| OFF Time (seconds) | | N/A | N/A | |

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Image /page/33/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biomedical Research, LTD c/o Ms. Anne-Marie Keenan Quality & Regulatory Engineer Parkmore Business Park West Galway, Ireland

Re: K112258

Trade/Device Name: Neurotech Plus, Type 413 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, NYN, IPF Dated: November 30, 2011 Received: December 5, 2011

Dear Ms. Keenan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to tegans manative possible in the Medical Device Artic commerce prior to May 28, 1776, the encoment and of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvine the general controls provisions of the Act. The You may, merciole, market the device, basjon to the most for annual registration, listing of general controls provisions of the rict interest and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note: CDICT does not overaliate and more be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see acove) interior major regulations affecting your device can be may be subject to additional controls: "Existing migral" - " " " " a ddition, FDA may found in the Code of I caccai resgments concerning your device in the Federal Register.

JAN - 9 2012

34

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Ja

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

35

Indications for Use

510(k) Number (if known):

Device Name:

Neurotech Plus, Type 413

Indications for Use:

The Neurotech Plus device is indicated for the following:

In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440:

NMES Indications	TENS Indications
Maintain or increase the range of motion	Symptomatic relief and management of chronic, intractable pain
Prevention or retardation of disuse atrophy	Relief of pain associated with arthritis
Re-educate muscles	Adjunctive treatment in the management of post-surgical and post-trauma pain
Relax muscle spasms	Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only)
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

In Neuromuscular Electrical Stimulation (NMES) only mode, models 437 & 441:

NMES Indications
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

In Transcutaneous Electrical Nerve Stimulation (TENS) only mode, model 438:

TENS Indications
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112258