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

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

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
Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only)

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

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

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Neurotech Plus, Type 413) and, as such, it does not describe an acceptance criteria study in the way one might for an AI/ML device or software performance. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria and results.

However, I can extract information related to the device's characteristics and the comparison made to establish substantial equivalence, which is a form of meeting "acceptance criteria" in the context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" is not explicitly stated as performance metrics like sensitivity/specificity for a diagnostic AI. Instead, substantial equivalence is established by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially the detailed technical specifications of the Neurotech Plus and how they compare to the predicate devices.

The tables (7.1 through 7.10) in the document provide a detailed comparison of the Neurotech Plus models with their respective predicate devices across various electrical stimulation parameters. These comparisons serve as the basis for demonstrating that the new device performs "as well as or better than" the listed predicate.

Below is an example of an abstracted table, as the original tables (7.1-7.10) are extensive and detailed for each model. I will use the information from Table 7.1 for Model 431 as an example comparison, highlighting how the new device's parameters compare to the predicate devices.

Abstracted Comparison Table (Example for Neurotech Plus Model 431 vs. Predicates)

Characteristic	Acceptance Criteria (Predicate Device K061516: Staodyn Max / K971437: Bionicare / K082011: MediTens)	Neurotech Plus Model 431 Reported Performance	Comparison Outcome (for this submission's purpose)
Waveform	Pulsed, symmetric, biphasic (Staodyn Max, MediTens); Pulsed, Monophasic (Bionicare)	Pulsed, symmetric, biphasic	Similar to Staodyn Max & MediTens
Shape	Rectangular (Staodyn Max); Rectangular, with interphase interval (MediTens); Exponential, Spike (Bionicare)	Rectangular, with interphase interval	Similar to MediTens
Max Output Voltage (500 Ω)	30.0V (Staodyn Max); 12V (Bionicare); 37.5V (MediTens)	35.0V	Within range of predicates (or comparable)
Max Output Current (500 Ω)	60.0mA (Staodyn Max); 24mA (Bionicare); 75.0mA (MediTens)	70.0mA	Within range of predicates (or comparable)
RMS Output Voltage (500 Ω)	8.9V (Staodyn Max); 4.3V (Bionicare); 6.5V (MediTens)	7.8V	Within range of predicates (or comparable)
RMS Output Current (500 Ω)	17.8mA (Staodyn Max); 8.6mA (Bionicare); 13mA (MediTens)	15.7mA	Within range of predicates (or comparable)
Primary Phase Duration	60-350uS (Staodyn Max); 640 μδ (Bionicare); 150uS (MediTens)	250uS	Within range of predicates (or comparable)
Pulse Duration	700uS (Staodyn Max); 640 μS (Bionicare); 400μς (MediTens)	400-600uS (uS both phases + 100µS interphase delay)	Within range of predicates (or comparable)
Frequency	80 to 125 Hz (Staodyn Max); 100 Hz (Bionicare); 4 to 99 Hz (MediTens)	4 to 125Hz	Within range of predicates (or comparable)
Net Charge (500 Ω)	0 μC (Staodyn Max, MediTens); 21 μC (Bionicare) *Method for 0μC specified for Staodyn & MediTens	0 μC @ 500 Ω (Symmetric, biphasic and leading polarity alternates for each successive pulse)	Similar to Staodyn Max & MediTens
Max Phase Charge (500 Ω)	9 to 21 μC (Staodyn Max); 21 μC (Bionicare); 7.5 to 11.25 μC (MediTens)	10.5 to 17.5 μC	Within range of predicates (or comparable)
Max Current Density	0.71mA/cm² (Staodyn Max); 0.08 mA/cm² (Bionicare); 0.672mA/cm² (MediTens)	0.80mA/cm²	Within range of predicates (or comparable)
Max Average Current	5.3mA (Staodyn Max); 2.1mA (Bionicare); 2.25mA (MediTens)	3.5mA	Within range of predicates (or comparable)
Max Average Power Density	6.3 mW/cm² (Staodyn Max); 0.34 mW/cm² (Bionicare); 4.4mW/cm² (MediTens)	6.2mW	Within range of predicates (or comparable)

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No new clinical tests have been submitted as part of this premarket notification." Therefore, there is no "test set" in the context of patient data, nor is there information on sample size or data provenance from a prospective or retrospective study. The primary "test" for this submission is a comparison of engineering specifications against predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no new clinical tests were conducted and no patient-specific "test set" was used, there were no experts involved in establishing a "ground truth" for such a test set. The "ground truth" for a 510(k) is implicitly the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is a 510(k) for a TENS/NMES device, not an AI/ML diagnostic or treatment assistance software. No MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a hardware medical device (Neurotech Plus, Type 413), not a standalone algorithm.

7. The Type of Ground Truth Used

In the context of a 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the previously established regulatory clearance of the predicate devices. The technological characteristics and intended use of the Neurotech Plus were compared to these already approved devices. The ground truth is effectively the regulatory precedent set by the predicate devices.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and therefore does not involve a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary

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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, WestGalway, 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

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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

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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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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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)

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.

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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.

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Table 6.1+.1Model 431	ScreenText	Intensity	Rate(Hz or pps)	Pulse Width(usec)	Cont(sec.)	Relax(sec.)	RampUp(sec.)	RampDown(sec.)	Additional Functions	TreatmentTime(minutes)
1	P1	Adj	125 to 4;modulates(decreases) between125 to 4 in 12second cycle -remains at 125 for 3seconds and 4 for 3seconds of cycletime(see Note 1)	150 to 250;modulates(increases) between150 to 250 in 12second cycle -remains at 150 for 3seconds and 250 for3 seconds of cycletime(see Note 1)						Open
2	P2	Adj	99	200					Burst Toggle - 4 Hz, 250 usec Activation andoutput remains constant after pressing the burstbutton. Press Burst again to cancel. No rampup/down will be implemented	Open
3	P3	Adj	Ch 1: 4Ch 2: 125	200					Criss-cross Function, Burst - Ch1 125 Hz, 200 usec& Ch2 125 Hz, 200 usec. Activation and outputremains constant for 10 minutes after burst buttonpressed. No ramp up/down will be implemented(See note 2)	Open
4	P4	Adj	4	250					Burst - 125 Hz, 175 usec. Activation and outputremains constant while pressing burst button. Noramp up/down will be implemented	Open
5	P5	Adj	50	300	5		15	1.0		30
6	P6	Adj	50	300	5		10	1.0	Trigger	30
7	P7	Adj	50	300	5		5	1.0	Trigger	30
8	P8	Adj	35	300	5		10	1.0	Trigger	30
9	P9	Adj	8	300	5		5	1.0	Trigger	20
10	P10	Adj	10070	100200	5		15	1.0		9010
		Adj	10070	100200	5		15	1.0		9020
		Adj	100	100						90
Table 6.1.2Model 432	ScreenText	Intensity	Rate(Hz or pps)	Pulse Width(usec)	Contract(sec.)	Relaxation(sec.)	Ramp Up(Sec.)	RampDown(Sec.)	Additional Functions	Treatment Time(minutes)
1	P1	Adj	125 to 4;modulates (decreases)between 125 to 4 in 12second cycle - remains at125 for 3 seconds and 4for 3 seconds of cycletime	150 to 250;modulates (increases)between 150 to 250 in12 second cycle -remains at 150 for 3seconds and 250 for 3seconds of cycle time					Burst-4Hz, 250 usec.Activation and outputremains constantwhile pressing burstbutton. No rampup/down will beimplemented	Open
2	P2	Adj	99	200						Open
3	P3	Adj	Ch 1: 4Ch 2: 125	200					Criss-cross Function,Burst - Ch1 125 Hz,200 usec & Ch2 125Hz, 200 usec.Activation and outputremains constant for10 minutes after burstbutton pressed. Noramp up/down will beimplemented.(See note 2)	Open
4	P4	Adj	4	250					Burst-125Hz, 175usec. Activation andoutput remainsconstant whilepressing burst button.No ramp up/down willbe implemented	Open
5	P5	Adj	50	300	5	15	1.0	0.5	Trigger	30
6	P6	Adj	50	300	5	10	1.0	0.5	Trigger	30
7	P7	Adj	50	300	5	5	1.0	0.5	Trigger	30
8	P8	Adj	35	300	5	10	1.0	0.5	Trigger	20
9	P9	Adj	8	300	5	5	1.0	.5	Trigger	20
10	P10	Adj	70100	100200	5	15	1.0	0.5		70
			70100	100200	5	15	1.0	0.5		70

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Table 6.1.3Model 433	ScreenText	Intensity	Rate(Hz or pps)	Width(usec)	Contraction(sec.)	Relaxation(sec.)	Ramp Up(Sec.)	RampDown(Sec.)	AdditionalFunctions	TreatmentTime(minutes)
1	P1	Adjustable	125 to 4;modulates(decreases)between 125 to4 in 12 secondcycle - remainsat 125 for 3seconds and 4for 3 seconds ofcycle time	150 to 250;modulates(increases)between 150 to250 in 12second cycle -remains at 150for 3 secondsand 250 for 3seconds ofcycle time						Open
2	P2	Adjustable	125	175						Open
3	P3	Adjustable	4	250					Burst -Frequency of 4Hz, pulse widthof 250 usec.Activation andoutput remainsconstant whilepressing burstbutton. Willramp down over 3sec. and up over 3sec	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 125Hz. pulse widthof 175 usec.Activation andoutput remainsconstant whilepressing burstbutton. No rampupodwn will beimplemented.	70
10	P10	Adjustable	70	200	5	15	1.0	0.5	Trigger	20
Table 6.1.4Model 434	ScreenText	Intensity	Rate(Hz or pps)	Width(usec)	Contraction(sec.)	Relaxation(sec.)	RampUp(Sec.)	RampDown(Sec.)	AdditionalFunctions	TreatmentTime(minutes)
1	P1	Adjustable	80	120	ContinuousStimulation		2			Open
2	P2	Adjustable	2	180	ContinuousStimulation		2			Open
3	P3	Adjustable	80	70-120	ContinuousStimulation		2			Open
4	P4	Adjustable	80/2	180	ContinuousStimulation		2			Open
5	P5	Adjustable	9/2	300	ContinuousStimulation		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 6.1.5Model 436	ScreenText	Intensity	Rate(Hz or pps)	Width(usec)	Contraction(sec.)	Relaxation(sec.)	Ramp Up(Sec.)	Ramp Down(Sec.)	Additional Functions	TreatmentTime(minutes)
1	P1	Adjustable	125 to 4:modulates(decreases)between 125 to 4in 12 secondcycle - remains at125 for 3 secondsand 4 for 3seconds of cycletime	150 to 250;modulates(increases)between 150 to250 in 12 secondcycle - remains at150 for 3 secondsand 250 for 3seconds of cycletime	NA	NA	NA	NA	None	Open
2	P2	Adjustable	125 to 4;modulates(decreases)between 125 to 4in 12 secondcycle - remains at125 for 3 secondsand 4 for 3seconds of cycletime	50 to 100;modulates(increases)between 50 to 100in 12 second cycle- remains at 50 for3 seconds and 100for 3 seconds ofcycle time	NA	NA	NA	NA	None	Open
3	P3	Adjustable	125	150	NA	NA	NA	NA	Burst - Frequency is80hz, pulse width 300usec with 8 pulses perburst;2 bursts per second. 12second cycle time - 2seconds modulationfrom normal to burst, 8seconds at burst, 2seconds modulatingfrom burst to normal.Frequency willincrement/decrementduring the transitionto/from burst.	Open
4	P4	Adjustable	80	300	10	25(RemoveBeep)	1.5	1.5	Trigger	30
5	P5	Adjustable	50	300	10	20 (RemoveBeep)	1.5	1.5	Trigger	30
6	P6	Adjustable	35	300	5	5	1.5	1.5	Trigger	30

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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 LEseconds	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 Children2seconds	2seconds
A . A . APulse Width	2000 Js	Carles Market225 Us	2500s	2700s
Carreland ContractFrequency	0Hz	55Hz------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	55Hz------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	A50Hz------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
DurationSTERE COLORIO CONSULTION	20 minutesA Land State State of States of Active Andrewi	25 minutes	30 minutes	40 minutes
Table 6.1.6Model 437	ProgramParticle Property of Children Comments of Children	Program211-2017 Com	Program 3Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children States of th	Program

Table 6.1.7Model 438	ScreenText	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) between150 to 250 in 12 second cycle -remains at 150 for 3 seconds and250 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 50to 100 in 12 second cycle -remains at 50 for 3 seconds and100 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 - 4Channel 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) between250 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 50to 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) between150 and 250 in 10 second cycle(5/5)	NA	45

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Table 6.1.8Model 439	ScreenText	Intensity	Rate(Hz or pps)	Width(usec)	Contraction(sec.)	Relaxation(sec.)	Ramp Up(Sec.)	Ramp Down(Sec.)	AdditionalFunctions	TreatmentTime(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

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Table 6.1.9Model 440	ScreenText	Intensity	Rate(Hz or pps)	Width(usec)	Contraction(sec.)	Relaxation(sec.)	Ramp Up(Sec.)	RampDown(Sec.)	Additional Functions	TreatmentTime(minutes)
1	P1	Adjustable	125 to 4;modulates(decreases)between 125 to 4in 12 second cycle- remains at 125for 3 seconds and4 for 3 seconds ofcycle time	150 to 250;modulates(increases)between 150 to250 in 12 secondcycle - remains at150 for 3 secondsand 250 for 3seconds of cycletime						Open
2	P2	Adjustable	99 to 50;modulates(decreases)between 99 and 50in 8 second cycle(4/4)	150 to 250;modulates(increases)between 150 to250 in 8 secondcycle (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
	ScreenText	Intensity	Rate(Hz or pps)	Width(usec)	Contraction(sec.)	Relaxation(sec.)	RampUp(Sec.)	RampDown(Sec.)	AdditionalFunctions	TreatmentTime(minutes)
5.1.10441	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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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

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Table 7.1		Neurotech PlusModel 431	Predicate DeviceStaodyn MaxK061516	PredicateBionicareK971437	PredicateMediTensK082011
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 399Hz, 150μS
Waveform (e.g pulsed monophasic, biphasic)		Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasicRectangular	Pulsed, MonophasicExponential, 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 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	30.0V @ 500 ΩNot availableNot available	12V 500ΩNot availableNot available	37.5V @ 500 Ω70.0V@ 2 kΩ71.8V @ 10 kΩ
Maximum Output Current (specify units)(+/- 10%)		70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0mA @ 10 kΩ	60.0 mA @ 500 ΩNot availableNot available	24mA @ 500ΩNot availableNot available	75.0mA @ 500 Ω35.0mA @ 500 Ω7.0mA @ 10 kΩ
RMS Output Voltage (volts)(+/- 10%)		7.8V @ 500 Ω	8.9V @ 500 Ω	4.3VEstimated assuming a square pulse shape 0.64ms	6.5V@500Ω
		16.8V @ 2 kΩ7.9V @ 10 kΩ	Not availableNot available	Not availableNot available	14.2V@2kΩ4.95V@10kΩ
RMS Output Current (specify units)(+/- 10%)		15.7mA @ 500 Ω	17.8mA @ 500 Ω	8.6mA	13mA@500Ω
		8.4mA @ 2 kΩ0.8mA @ 10 kΩ	Not availableNot available	Not availableNot available	7.1mA@2kΩ0.5mA@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 PlusModel 431	Predicate DeviceStaodyn MaxK061516	PredicateBionicareK971437	PredicateMediTensK082011
	(units) state range, ifapplicable)(both phases, ifasymmetrical)
	Net Charge(microcoulombs (uC) per pulse) (if zero,state method of achieving zero net charge.)	0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive pulse.	0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive pulse.	21 μC @ 500 Ω	0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive 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 forworst case (highest) output}	$0.80mA/cm^2(T=1sec)$	Program EUsing 2" square electrode=17.8 mA/25 cm²= 0.71mA/cm²	$0.08 mA/cm^2$i.e. 8.6mA/108 cm²Using 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), (usingsmallest 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 EUsing 2" square electrode	$0.34 mW/cm^2$	$4.4mW/cm^2$50mm round electrode
	Burst Mode (i.e., pulse (a) Pulses per bursttrains):	N/ABurst mode is simply an alternatefrequency-pulse witdhcombination. There are actuallyno intermittent bursts	8	N/A	N/ABurst mode is simply an alternatefrequency-pulse witdhcombination. There are actuallyno 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) xLine (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

{14}------------------------------------------------

Page 15 of 33

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Table 7.2	Mode or Program Name	Neurotech PlusModel 432	Predicate DeviceStaodyn MaxK061516	PredicateBionicareK971437	PredicateMediTensK082011Program 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, biphasicRectangular, with interphase interval	Pulsed, symmetric, biphasicRectangular	Pulsed, MonophasicExponential, Spike	Pulsed, symmetric, biphasicRectangular, 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	4.3VEstimated assuming a square pulseshape 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 PlusModel 432	Predicate DeviceStaodyn MaxK061516	Predicate BionicareK971437	Predicate MediTensK082011
applicable)(both phases, asymmetrical) ifNet Charge(microcoulombs (uC) per pulse) (if zero, state method of achieving zero net charge.)	0 μC @ 500 ΩSymmetric, biphasic and leading polarity alternates for each successive pulse.	0 μC @ 500 ΩSymmetric, biphasic and leading polarity alternates for each successive pulse.	21 μC @ 500Ω	0 μC @ 500 ΩSymmetric, 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 EUsing 2" square electrode=17.8 mA/25 cm²= 0.71mA/cm²	0.08 mA/cm²i.e. 8.6mA/108 cm²Using 12 x 9 cm electrodes	0.672mA/cm²5cm 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/cm²Program EUsing 2" square electrode	0.34 mW/cm²	4.4mW/ cm²50mm 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 PlusModel 433	Plan 2	Pulsed, symmetric, biphasicRectangular, with interphase interval	35.0V @ 500 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0mA @ 10 kΩ	7.3V @ 500 Ω	14.6mA @ 500 Ω7.8mA @ 2 kΩ0.8mA @ 10 kΩ	150-250uS	400-600uS (uS both phases +100µS interphase delay)	4-125Hz	Yes	60-350uS
Predicate DeviceStaodyn MaxK061516	Program E (Highest output)	Pulsed, symmetric, biphasicRectangular	30.0V @ 500 ΩNot availableNot available	60.0 mA @ 500 ΩNot availableNot available	8.9V @ 500 Ω	17.8mA @ 500 ΩNot availableNot available	Not available	700uS (350 uS both phases)	80 to 125 Hz	Yes	N/A
PredicateBionicareK971437	Only has 1 mode	Pulsed, MonophasicExponential, Spike	12V 500ΩNot availableNot available	24mA @ 500ΩNot availableNot available	4.3VEstimated assuming a square pulse shape 0.64ms	8.6mANot availableNot available	Not available	640 µS	100 Hz
PredicateMediTensK082011	Program 399Hz, 150μS	Pulsed, symmetric, biphasicRectangular, with interphase interval	37.5V @ 500 Ω70.0V@ 2 kΩ71.8V @ 10 kΩ	75.0mA @ 500 Ω35.0mA @ 500 Ω7.0mA @ 10 kΩ	6.5V@500Ω	Not available14.2V@2kΩ4.95V@10kΩ	Not available	150uS400μ S	Both phases4 to 99 Hz	Yes	100 to 150uS

Page 18 of 33

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	Neurotech PlusModel 433	Predicate DeviceStaodyn MaxK061516	PredicateBionicareK971437	PredicateMediTensK082011
applicable)(both phases,if asymmetrical)
Net Charge(microcoulombs (uC) per pulse) (if zero,state method of achieving zero net charge.)	0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive pulse.	0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive pulse.	21 μC @ 500Ω	0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive 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 EUsing 2" square electrode=17.8 mA/25 cm²= 0.71mA/cm²	0.08 mA/cm²i.e. 8.6mA/108 cm²Using 12 x 9 cm electrodes	0.672mA/cm²5cm 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), (usingsmallest electrode conductive surface area)1 @ 500 Ω Where T is the output duration}	5.5mW (T=1sec)	6.3 mW/cm²Program EUsing 2" square electrode	0.34 mW/cm²	4.4mW/cm²50mm round electrode
Burst Mode (i.e., pulse (a) Pulses per bursttrains):	N/ABurst mode is simply an alternatefrequency-pulse witdh combination.There are actually no intermittentbursts	8	N/A	N/ABurst mode is simply an alternatefrequency-pulse witdhcombination. There are actuallyno 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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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 PlusModel 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 ΩSymmetric, biphasic and leading polarity
Predicate DeviceStaodyn MaxK061516	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 ΩSymmetric, biphasic and
Predicate DeviceMediTensK082011	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 ΩSymmetric, biphasic and leading

{20}------------------------------------------------

		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 EUsing 2" square electrode=17.8 mA/25 cm²= 0.71mA/cm²	0.672mA/cm²5cm 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/cm²Program EUsing 2" square electrode	4.4mW/ cm²50mm round electrode
Burst Mode (i.e., pulse trains):	(a) Pulses per burst	N/ABurst mode is simply an alternatefrequency-pulse witdh combination. Thereare actually no intermittent bursts	8	N/ABurst mode is simply an alternatefrequency-pulse witdh combination.There are actually no intermittentbursts
	(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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Table 7.5		Neurotech PlusModel 436	Predicate DeviceStaodyn MaxK061516	Neurotech PlusModel 436	Predicate DeviceMediStim XPK082011
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 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	30.0V @ 500 ΩNot availableNot available	35.0V @ 500 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	37.5V @ 500 Ω70.0V@ 2 kΩ71.8V @ 10 kΩ
Maximum Output Current (specify units)(+/- 10%)		70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0mA @ 10 kΩ	60.0 mA @ 500 ΩNot availableNot available	70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0mA @ 10 kΩ	75.0mA @ 500 Ω35.0mA @ 500 Ω7.0mA @ 10 kΩ
RMS Output Voltage (volts)(+/- 10%)		6.8V @ 500 Ω14.5V @ 2 kΩ7.8V @ 10 kΩ	Not availableNot availableNot available	7.7V @ 500 Ω16.4V @ 2 kΩ6.3V @ 10 kΩ	6.5 V @ 500 Ω12.1V @ 2 kΩ7.1V @ 10 kΩ
RMS Output Current (specify units)(+/- 10%)		13.6mA @ 500 Ω7.3mA @ 2 kΩ0.8mA @ 10 kΩ	Not availableNot availableNot available	15.3mA @ 500 Ω8.2mA @ 2 kΩ0.6mA @ 10 kΩ	13.0mA @ 500 Ω6.0mA @2 kΩ0.7mA @ 10 kΩ
Duration of primary (depolarizing) phase (usec)		50-250uS	60-350uS	300uS	150-300uS
Pulse Duration (usec)		200-600uS (uS bothphases + 100μςinterphase delay)	700uS (350 uS bothphases)	600 uS (100 uS bothphases + 100μςinterphase delay)	400-700us (100 uS bothphases + 100μ Sinterphase delay)
Frequency (Hz)[ or Rate (pps) ]		4-125Hz	Not available	35-80Hz	2-100Hz
For multiphasic waveforms only:	Symmetrical phases?Phase duration (include units) staterange, if applicable)(both phases, ifasymmetrical)	N/A	N/A	N/A	N/A
	Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achievingzero net charge.)	0 μC @ 500 ΩSymmetric, biphasic andleading polarity alternates	0 μC @ 500 ΩSymmetric, biphasic andleading polarity alternates	0 μC @ 500 ΩSymmetric, biphasic andleading polarity alternates	0 μC @ 500 ΩSymmetric, biphasic andleading polarity alternates
Table 7.5		Neurotech PlusModel 436	Predicate DeviceStaodyn MaxK061516	Neurotech PlusModel 436	Predicate DeviceMediStim XPK082011
		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 electrodeconductive 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 PlusModel 437	Predicate DeviceMediStim XPK082011
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 + 100µSinterphase delay)	400-700us (100 uS both phases + 100μSinterphase delay)
Frequency (Hz)[ or Rate (pps) ]		50-60Hz	2-100Hz
For multiphasic waveforms only:	Symmetrical phases?	N/A	N/A
	Phase duration (include units) staterange, if applicable)(both phases, ifasymmetrical)	N/A	N/A
Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achievingzero net charge.)		0 μC @ 500 ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse.	0 μC @ 500 ΩSymmetric, biphasic and leading polarityalternates 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 PlusModel 437	Predicate DeviceMediStim XPK082011
Maximum Average Current (average absolute value), mA {@ 500 Ω}		1.93mA	Not available
Maximum Average Power Density, (W/ cm2), (using smallest electrodeconductive 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 PlusModel 438	Predicate DeviceStaodyn MaxK061516
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 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	30.0V @ 500 ΩNot availableNot available
Maximum Output Current (specify units)(+/- 10%)		70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0mA @ 10 kΩ	60.0 mA @ 500 ΩNot availableNot available
RMS Output Voltage (volts)(+/- 10%)		8.7V @ 500 Ω18.7V @ 2 kΩ7.8V @ 10 kΩ	Not availableNot availableNot available
RMS Output Current (specify units)(+/- 10%)		17.5mA @ 500 Ω9.4mA @ 2 kΩ0.8mA @ 10 kΩ	Not availableNot availableNot 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 ΩSymmetric, biphasic and leading polarity alternates for each successive pulse.	0 μC @ 500 ΩSymmetric, 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

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and the comments of the comments of the comments of

. . . . . .

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Table 7.8		Neurotech PlusModel 439	Predicate DeviceStaodyn MaxK061516	PredicateMediTensK082011
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 interphaseinterval	Rectangular	Rectangular, with interphaseinterval
Maximum Output Voltage (volts)(+/- 10%)		35.0V @ 500 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	30.0V @ 500 ΩNot availableNot available	37.5V @ 500 Ω70.0V @ 2 kΩ71.8V @ 10 kΩ
Maximum Output Current (specify units)(+/- 10%)		70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0mA @ 10 kΩ	60.0 mA @ 500 ΩNot availableNot available	75.0mA @ 500 Ω35.0mA @ 500 Ω7.0mA @ 10 kΩ
RMS Output Voltage (volts)(+/- 10%)		6.8V @ 500 Ω14.6V @ 2 kΩ7.8V @ 10 kΩ	8.9V @ 500 ΩNot availableNot available	6.5V @500Ω14.2V @2kΩ4.95V@10kΩ
RMS Output Current (specify units)(+/- 10%)		13.6mA @ 500 Ω7.3mA @ 2 kΩ0.8mA @ 10 kΩ	17.8mA @ 500 ΩNot availableNot available	13mA@500Ω7.1mA@2kΩ0.5mA@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)	400µSBoth phases
Frequency (Hz) [ or Rate (pps) ]For multiphasic waveformsonly:		4-125Hz	80 to 125 Hz	4 to 99 Hz
Symmetrical Phases?Phase Duration		Yes100 to 250µS	Yes60-350uS	Yes100 to 150uS
Net Charge(microcoulombs (uC) per pulse) (if zero, state method ofachieving zero net charge.)		0 µC @ 500 ΩSymmetric, biphasic andleading polarity alternates foreach successive pulse.	0 µC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for eachsuccessive pulse.	0 µC @ 500 ΩSymmetric, biphasic andleading polarity alternates foreach 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 PlusModel 439	Predicate DeviceStaodyn MaxK061516	PredicateMediTensK082011
Maximum Current Density (mA/cm², r.m.s){@ 500 Ω Where T is the output duration)		0.70mA/cm²(T=1sec)	Program EUsing 2" square electrode=17.8 mA/25 cm²= 0.71mA/cm²	0.672mA/cm²5cm 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 electrodeconductive surface area) {@ 500 Ω Where T is the output duration}		4.7mW (T=1sec)	6.3 mW/cm²Program EUsing 2" square electrode	4.4mW/cm²50mm round electrode
Burst Mode (i.e., pulse trains):	(a) Pulses per burst	N/ABurst mode is simply analternate frequency-pulse widthcombination. There are actuallyno intermittent bursts	8	N/ABurst mode is simply analternate frequency-pulse widthcombination. There are actuallyno 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 PlusModel 440	Predicate DeviceStaodyn MaxK061516	PredicateMediTensK082011
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 + 100μδinterphase delay)	700uS (350 uS both phases)	400μS
Frequency (Hz)[ or Rate (pps) ]	4-125Hz	80 to 125 Hz	4 to 99 Hz
For multiphasic waveformsonly:	N/A	Yes	Yes
Net Charge(microcoulombs (uC) per pulse)(if zero, state method of achieving zero net charge.)	100 to 250μς0 μC @ 500 ΩSymmetric, biphasic and leading polarityalternates for each successive pulse.	60-350uS0 μC @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for each successivepulse	100 to 150uS0 μ€ @ 500 ΩSymmetric, biphasic and leadingpolarity alternates for each successivepulse.
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 EUsing 2" square electrode=17.8 mA/25 cm²	0.672mA/cm²5cm round electrode)
Table 7.9		Neurotech PlusModel 440	Predicate DeviceStaodyn MaxK061516	PredicateMediTensK082011
Maximum Average Current (average absolute value),mA { @ 500 Ω}		2.66mA	= 0.71mA/cm²5.3mA	2.25mA
Maximum Average Power Density. (W/ cm²), (using smallestelectrode conductive surface area){ @ 500 Ω Where T is the output duration)		4.7mW (T=1sec)	6.3 mW/cm²Program EUsing 2" square electrode	4.4mW/cm²50mm round electrode
Burst Mode (i.e.. pulse trains):	(a) Pulses per burst	N/A	8	N/A
		Burst mode is simply an alternatefrequency-pulse witdh combination.There are actually no intermittent bursts		Burst mode is simply an alternatefrequency-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 PlusModel 441	Predicate DeviceMediStim XPK082011
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 Ω75.0V @ 2 kΩ70.3V @ 10 kΩ	37.5V @ 500 Ω70.0V@ 2 kΩ71.8V @ 10 kΩ
Maximum Output Current (specify units)(+/-10%)		70.0mA @ 500 Ω37.5mA @ 2 kΩ7.0 mA @ 10 kΩ	75.0mA @ 500 Ω35.0mA @ 500 Ω7.0mA @ 10 kΩ
RMS Output Voltage (volts)(+/-10%)		8.5V @ 500 Ω18.3V @ 2 kΩ7.0V @ 10 kΩ	6.5 V @ 500 Ω12.1V @ 2 kΩ7.1V @ 10 kΩ
RMS Output Current (specify units)(+/- 10%)		17.1mA @ 500 Ω9.1mA @ 2 kΩ0.7mA @ 10 kΩ	13.0mA @ 500 Ω6.0mA @ 2 kΩ0.7mA @ 10 kΩ
Duration of primary (depolarizing) phase (usec)		300uS	150-300uS
Pulse Duration (usec)		400uS (100 uS both phases + 100μSinterphase delay)	400-700us (100 us both phases + 100µSinterphase delay)
Frequency (Hz) [ or Rate (pps) ]		10-99Hz	2-100Hz
For multiphasic waveforms only:	Symmetrical phases?	N/A	N/A
	Phase duration (include units) staterange, if applicable)(both phases, ifasymmetrical)	N/A	N/A
	Net Charge(microcoulombs (uC) per pulse) (if zero, state method of achievingzero net charge.)	0 μC @ 500 ΩSymmetric, biphasic and leading polarityalternates for each successive pulse.	0 μC @ 500 ΩSymmetric, biphasic and leading polarityalternates 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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ે

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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

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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,

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

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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

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).