Predicate Devices

K083105, K082011, K061516, K021100, K971437

Reference Devices

K083105, K082011, K061516, K021100, K971437

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard electrical stimulation device (NMES and TENS) with pre-set programs and a patented conductive garment technology. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML.

Therapeutic

Yes
The "Indications for Use" section explicitly states that the device is intended to "maintain or increase range of motion," "prevent or retard disuse atrophy," "re-educate muscles," "relax muscle spasms," "increase blood circulation," and "provide symptomatic relief and management of chronic pain." These are all therapeutic applications.

Diagnostic

No

Explanation: The device description and intended use clearly state that the Kneehab XP is a therapeutic device designed for neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) to treat various conditions, not to diagnose them.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "portable, battery operated, combination device" that includes a "rechargeable control unit," "garment," "adhesive electrodes," and "battery charger." This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Kneehab XP, Type 412/421 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Kneehab XP Function: The Kneehab XP is an electrical stimulation device that applies electrical currents to the body externally through electrodes and a garment. It is used for therapeutic purposes (muscle strengthening, pain relief, etc.) and does not analyze any biological samples.

The description clearly outlines its function as a combination NMES and TENS device for treating conditions related to the knee and surrounding muscles. This falls under the category of physical therapy or pain management devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Kneehab XP, Type 412/421, Indications for use are as follows:

In NMES mode (Programs 1-6) the Kneehab XP is intended to:

Maintain or increase the range of motion.
Prevention or retardation of disuse atrophy
Re-educate muscles
Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
Relax muscle spasms
Increase blood circulation

In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:

Provide symptomatic relief and management of chronic, intractable pain.
Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee

Product codes

IPF, GZJ, NYN

Device Description

The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.

The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.

All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee, quadriceps

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)

K083105, K082011, K061516, K021100, K971437

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K110350

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 stylized font, with the words "bio-medical research ltd." written in a smaller font below the letters. The letters "bmr" are connected to each other.

Bio-Medical Research Ltd.

AUG - 3 2011 Parkmore Business Park West, Galway, Ireland Tel: +353 (0)91 774300 - Fax: +353 (0)91 774301

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

1. Contact Details

Name:	Anne-Marie Keenan
Title:	Quality/Regulatory Engineer
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:	July 25, 2011.

2. Device Name

Trade Name of Device:	Kneehab XP, Type 412/421
Common Name:	Transcutaneous Electrical Nerve Stimulator
Powered Muscle Stimulator
Regulation Number:	21 CFR 882.5890
21 CFR 890.5850
Regulation Description:	Transcutaneous electrical nerve stimulator for pain relief
Powered muscle stimulator
Product Code:	IPF, GZJ, NYN
Device Class:	2

3. Identification of Equivalent Legally Marketed Device

510(k) Number:	K083105
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	Kneehab XP Conductive Garment, Type 411

Directors: T. Kirwan (Chairman), Dr. P.A. Smith (Managing), Dr. B. McDonnell, C. Minogue, P. McGrath

1

Image /page/1/Picture/0 description: The image shows a blurry, high contrast image of what appears to be a collection of small, dark spots against a white background. The spots are irregularly shaped and scattered across the image. Due to the blurriness, it is difficult to determine the exact nature or origin of the spots.

510(k) Number:	K082011
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	MediStim XP, Type 281
510(k) Number:	K082011
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	MediTens XP, Type 458
510(k) Number:	K061516
Manufacturer:	Compex Technologies, Inc
Trade Name:	Staodyn Max Preset
510(k) Number:	K021100
Manufacturer:	Empi
Trade Name:	300 PV Complete Electrotherapy System
510(k) Number:	K971437
Manufacturer:	BioniCare Medical Technologies
Trade Name:	Bionicare® Stimulator System

4. Description of Device

The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.

The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with

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the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.

All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

5. Statement of Intended Use and Indications for Use

Kneehab XP, Type 412/421 delivers stimulation based on the principles of NMES and TENS. NMES may be defined as the application of electrical stimulation of the peripheral nervous system to contract a muscle, either through the direct activation of the motor neurons in the mixed peripheral nerve, or indirectly through reflex recruitment. TENS can be defined as a pain therapy based on the application of electrical stimuli to the skin via stimulation of the nerve fibers.

In NMES mode (Programs 1-6), the Kneehab XP, Types 412/421. is indicated for use as follows:

Maintain or increase the range of motion. 1.
Prevention or retardation of disuse atrophy 2.
Re-educate muscles 3.
1. Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
Relax muscle spasms 5.
Increase blood circulation 6.

Programs 1-6 use multipath technology.

3

| Program
Number | Duration
(Minutes) | Frequency/
Rate (Hz) | Pulse
Width
(µsec) | Ramp
Up
Time
(seconds) | Contraction
Time
(seconds) | Ramp
Down
Time
(seconds) | Relaxation
Time
(seconds) | Additional
Function | Indication
No. |
|-------------------|-----------------------|-------------------------|--------------------------|---------------------------------|----------------------------------|-----------------------------------|---------------------------------|------------------------|-------------------|
| P1 | 20 | 50 | 300-400 | 1 | 5 | 0.5 | 10 | Trigger | 4 |
| P2 | 20 | 50 | 300-400 | 1 | 10 | 0.5 | 10 | Trigger | 1, 2, 3, 5, 6 |
| P3 | 20 | 50 | 300-400 | 1 | 10 | 0.5 | 20 | Trigger | 1, 2, 3, 5, 6 |
| P4 | 20 | 50 | 300-400 | 1 | 10 | 0.5 | 30 | Trigger | 1, 2, 3, 5, 6 |
| P5 | 20 | 35 | 300-400 | 1 | 5 | 0.5 | 5 | Trigger | 1, 2, 3, 5, 6 |
| P6 | 20 | 70 | 300-400 | 1 | 10 | 0.5 | 50 | Trigger | 1, 2, 3, 5, 6 |

Neuromuscular Electrical Stimulation (NMES) Programs on Kneehab XP:

In TENS Mode (Programs 7 - 10), the Kneehab XP, Type 412/421 is indicated for use as follows:

Provide symptomatic relief and management of chronic, intractable pain 7.
Provide an adjunctive treatment in the management of acute, post-surgical or post-8. traumatic pain
Provide symptomatic relief and management of intractable pain and relief of pain 9. associated with arthritis
Provide an adjunctive therapy in reducing the level of pain and symptoms 10. associated with osteoarthritis of the knee

Transcutaneous Electrical Nerve Stimulation (TENS) Programs on Kneehab XP:

| Program
Number | Duration
(Minutes) | Frequency/
Rate (Hz) | Pulse
Width
(µsec) | Ramp
Up
Time
(seconds) | Contraction
Time
(seconds) | Ramp
Down
Time
(seconds) | Relaxation
Time
(seconds) | Additional
Function | Indication
No. |
|-------------------|-----------------------|-------------------------|--------------------------|---------------------------------|----------------------------------|-----------------------------------|---------------------------------|------------------------|-------------------|
| P7 | 30 | 99 | 300 | N/A | Continuous | N/A | N/A | No Trigger | 7-10 |
| P8 | 30 | 4 | 300 | N/A | Continuous | N/A | N/A | No Trigger | 7, 8, 9 |
| P9 | 30 | 125 | 175 | N/A | Continuous | N/A | N/A | No Trigger | 7, 8, 9 |

6. Summary of Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Kneehab XP, Type 412/421 device. A summary of the technological characteristics of the new device in comparison to the predicate device has been included below:

4

| General Comparison
Name of Device: | Proposed Device
Knechab XP | Predicate Device
Knechab XP
Conductive Garment | Predicate Device
MediTens XP | Predicate Device
MediStim XP | Predicate Device
Staodyn Max | Predicate Device
300 PV Complete
Electrotherapy System | Predicate Device
Blonicare® Stimulator
System |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number: | K110350 | K083105 | K082011 | K082011 | K061516 | K021100 | K971437 |
| Intended Use | The Kneehab XP is
intended to provide
transcutaneous
Neuromuscular Electrical
Stimulation (NMES) and
Transcutaneous
Electrical Nerve
Stimulation (TENS). | The Knechab XP is
intended to provide
transcutaneous
Neuromuscular Electrical
Stimulation (NMES) and
Transcutaneous
Electrical Nerve
Stimulation (TENS) | The MediTens XP is
intended to provide
Transcutaneous
Electrical Nerve
Stimulation (TENS). | The Knechab XP is
intended to provide
transcutaneous
Neuromuscular Electrical
Stimulation (NMES) and
Transcutaneous
Electrical Nerve
Stimulation (TENS) | The Knechah XP is
intended to provide
transcutaneous
Neuromuscular Electrical
Stimulation (NMES) and
Transcutaneous
Electrical Nerve
Stimulation (TENS) | The 300 PV is a
multifunction
electrotherapy device
intended to provide
Neuromuscular Electrical
Stimulation (NMES),
Transcutaneous
Electrical Nerve
Stimulation (TENS).
Interferential Current
Stimulation (IFS) and
Functional Electrical
Stimulation (FES). | The Bionicare is
battery operated TENS
stimulator producing
pulses at 100 Hz
Electrodes are applied to
the knee and thigh. |
| Prescriptive Use | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Indications for Use | In NMES mode
(Programs 1-6) the
Knechab XP is intended
to:
Maintain or increase
range of motion,
Prevention or retardation
of disuse atrophy,
Re-educate muscles,
Early post-surgical
quadriceps strengthening
and improved post
surgical knee stability
secondary to quadriceps
strengthening. Relax
muscle spasms &
Increase local blood
circulation

In TENS Mode
(Programs 7 - 9) the
Knechab XP is intended
to:
Provide symptomatic
relief and management of
chronic, intractable pain,
Provide an adjunctive
treatment in the
management of acute,
post-surgical or post-
traumatic pain, Provide | Muscle re-education of
the quadriceps.
Maintaining or increase
range of motion of the
knee joint. Prevention or
retardation of disuse
atrophy in the
quadriceps, Early post-
surgical quadriceps
strengthening and
improved post-surgical
knee stability secondary
to quadriceps
strengthening &
Increasing local blood
circulation. | The symptomatic relief
and management of
chronic intractable pain.
It is also an adjunctive
treatment in the
management of post-
surgical and post-
traumatic pain. The
device has no curative
value and should only be
used in conjunction with
medical supervision. | Neuromuscular Electrical
Stimulation (NMES) for
relaxation of muscle
spasms. prevention or
retardation of disuse
atrophy, increasing local
blood circulation, muscle
re-education, immediate
post-surgical stimulation
of calf muscles to
prevent venous
thrombosis and
maintaining or increasing
range of motion.

Transcutaneous
Electrical Nerve
Stimulation (TENS) for
an adjunctive treatment
in the management of
post-surgical and post-
traumatic acute pain
problems. | The Staodyn® Max
Preset Transcutaneous
Electrical Nerve
Stimulator Device is used
for the symptomatic
relief and management of
chronic intractable pain
and relief of pain
associated with arthritis.
It is also used as an
adjunctive treatment in
the management of post-
surgical and post-
traumatic pain | (TENS/NMES
Indications for use)
As a NMES device, the
300 PV is indicated for
the following conditions:
Re-educating muscles,
Relaxation of muscle
spasm. Increasing local
blood circulation,
Retarding or preventing
disuse atrophy.
Maintaining or
increasing range of
motion & Prevention of
venous thrombosis of the
calf muscles immediately
after surgery

As a TENS device, the
300 PV is indicated for
the following conditions:
Symptomatic relief and
management of chronic,
intractable pain and
Adjunctive treatment for
post-surgical and post-
trauma acute pain | Provide an adjunctive
therapy in reducing the
level of pain and
symptoms associated
with osteoarthritis of the
knee and for overall
improvement of the knee |

ン

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| General Comparison
Name of Device: | Proposed Device
Kneehab XP | Predicate Device
Kneehab XP
Conductive Garment | Predicate Device
MediTens XP | Predicate Device
MediStim XP | Predicate Device
Staodyn Max | Predicate Device
300 PV Complete
Electrotherapy System | Predicate Device
Bionicare® Stimulator
System | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510k Number: | K110350 | K083105 | K082011 | K082011 | K061516 | K021100 | K971437 | |
| | symptomatic relief and
management of
intractable pain. Relief of
pain associated with
arthritis.
Program 7 provides an
adjunctive therapy in
reducing the level of pain
and symptoms associated | | | | | | | |
| | with osteoarthritis of the
knee. | | | | | | | |
| Energy Used or
Delivered: | 3.6V
Rechargeable
Pack | NiMH
Battery | Same as proposed device | 9V Battery (type 6LR61) | 9V Battery (type 6LR61) | 3 x AAA Batteries | 2 x AA | 9V Battery (type 6LR61) |
| Unit: | Constructed from
injection moulded
thermosetting plastic
(ABS-PA-757) | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | 9V Battery (type 6LR61) | |
| Garment: | Contains an EEPROM.
Outer Fabric: 100%
Nylon, Inner Fabric: 70%
Polychloroprene & 30%
Polyurethane,
Binding: 82% Nylon &
18% Elastane.
Fastenings: 100% Nylon | Same as proposed device | Not Applicable (N/A) | N/A | N/A | N/A | Garment wraps around
knee and thigh, contains
conductive surfaces onto
which conductive gel is
applied. | |
| Electrode | Electrode A: 194 cm2,
Electrode B: 74 cm2,
Electrode C: 83 cm2 and
Electrode D: 66 cm2 | Same as proposed device | Industry standard
electrodes
5 x 5cm &
7 cm round
5 cm x 9cm etc. | Industry standard
electrodes
5 x 5cm &
7 cm round
5 cm x 9 cm etc. | Industry standard
electrodes
5 x 5cm &
7 cm round
5 cm x 9 cm etc. | Industry standard
electrodes
5 x 5cm &
7 cm round
5 cm x 9 cm etc. | 2 of 12 x 9 cm approx | |
| Lead Wires: | Over-moulded SATA
connector, splitting to 5
leads / studs. | Same as proposed device | Set of two (dark blue and
light blue), each lead
wire has 2 wires and
terminates with a 2mm
moulded pin for
connection to electrodes.
Constructed of PVC
insulated, containing 7-
strand tinsel copper with
interwoven Kevlar
reinforcing fibers. | Set of two (dark blue and
light blue), each lead
wire has 2 wires and
terminates with a 2mm
moulded pin for
connection to electrodes.
Constructed of PVC
insulated, containing 7-
strand tinsel copper with
interwoven Kevlar
reinforcing fibers. | Set of two, each lead
wire has 2 wires and
terminates with a 2mm
moulded pin for
connection to electrodes. | Set of two, each lead
wire has 2 wires and
terminates with a 2mm
moulded pin for
connection to electrodes. | Set of two, each lead
wire has 2 wires and
terminates with a 2mm
moulded pin for
connection to electrodes. | |
| Charger: | PC/ABS, complies with
IEC 60950 and UI, 1950 | Same as proposed device | N/A | N/A | N/A | YES, charges batteries
external to unit | N/A | |
| Standards Met | IEC 60601-1 (1998) & | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not Available | Not Available | |

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6

| General Comparison
Name of Device: | Proposed Device
Kneehab XP | Predicate Device
Kneehab XP
Conductive Garment | Predicate Device
MediTens XP | Predicate Device
MediStim XP | Predicate Device
Staodyn Max | Predicate Device
300 PV Complete
Electrotherapy System | Predicate Device
Bionicare® Stimulator
System |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------|--------------------------------------------|---------------------------------|--------------------------------------------------------------|-----------------------------------------------------|
| 510k Number: | K110350
1991, A2: 1995.
IEC 60601-2-10 (1987)
&
A1: 2001.
IEC 60601-1-2 (2001),
ISO 14971:2007,
ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2002 &
A1:2006
21 CFR 898
21 CFR 801 | K083105 | K082011 | K082011 | K061516 | K021100 | K971437 |
| Biocompatibility | Electrodes - K000947 | Same as proposed device | Electrodes - K970426,
K874469 & K965194 | Electrodes - K970426,
K874469 & K965194 | Not available | Not available | Not Available |
| Compatibility with the
environment & other
devices | Complies to IEC 60601-
1-2 Medical electrical
equipment - Part 1-2:
General requirements for
safety - Collateral
standard:
Electromagnetic
compatibility
Requirements and tests | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not Available | Not Available |
| Sterility | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Electrical &
Mechanical Safety | Complies to IEC 60601-1
Medical electrical
equipment - Part 1:
General requirements for
safety & IEC 60601-2-10
Medical electrical
equipment - Part 2-10:
Particular requirements
for the safety of nerve
and muscle stimulators | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | Not available |
| Chemical Safety | MSDS Sheet (Electrode
Gel) | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | Not available |
| Thermal Safety | Complies to IEC 60601-1
& IEC 60601-2-10 | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | Not available |
| Radiation Safety | N/A | N/A | N/A | N/A | Not available | Not available | Not available |

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UNIT Comparison	Proposed Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device
Name of Device:	Kneehab XP	Kneehab XP
Conductive Garment	MediTens XP	MediStim XP	Staodyn Max	300 PV Complete
Electrotherapy System
510k Number:	K110350	K083105	K082011	K082011	K061516	K021100
Manufacturer	China Turnkey Solutions
Logistics
(Shenzhen)
Co., Futian Free Trade
Zone. CHINA 518038	Same as proposed device	Same as proposed device	Same as proposed device	Compex Technologies	Empi
599 Cardigan Road
St. Paul,
Minnesota 55126-4099	BioniCare Medical
Technologies, Inc.,
47 R Loveton Circle
Sparks, MD 21152
-Method of
line
Isolation	No line connection	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	No line connection
Patient Leakage
Current	N/A	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device
No. of Output Modes	1	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Several. eg Hi Volt, FES.
Waveform/Shape	Pulsed, Symmetrical,
Biphasic. Rectangular
with interphase interval	Same as proposed device	Same as proposed device	Same as proposed device	Symmetrical Biphasic
Square	Asymmetric and
Symmetric square wave
options, Hi Volt pulse
option: exponential
spikes.	Monophasic spike
shaped pulse
No. of Output Channels	2	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	2
Synch/Alternating?	Synchronous
(Multiplexed)	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Synchronous and
alternating	Synchronous
-Method of channel
isolation	Transistor	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Transformer	unknown
Regulated Current or
Regulated Voltage	Regulated Current	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Claimed to be regulated
voltage
Software/Firmware/
Microprocessor
Control?	Yes	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device
Automatic Overload
Trip?	Yes, current limited,
indefinite short circuit
allowed	Same as proposed device	Same as proposed device	Same as proposed device	Unknown	Unknown	unknown
Automatic No-Load
Trip?	Yes	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	unknown
Automatic Shut Off?	Yes	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Same as proposed device	Unknown
Patient
Control?	Override Yes, pause button	Same as proposed device	Same as proposed device	Same as proposed device	Not available	Yes, Pause, FES modes	Yes stop button ends
treatment

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UNIT Comparison	Proposed Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device
Name of Device:	Kneehab XP	Kneehab XP
Conductive Garment	MediTens XP	MediStim XP	Staodyn Max	300 PV Complete
Electrotherapy System
510k Number:	K110350	K083105	K082011	K082011	K061516	K021100
Timer range (mins)	20 mins - open	Same as proposed device	Open	30 minutes - open	120 mins	5 mins to open	Open
Weight (unit)	116g (inc. batteries)	Same as proposed device	142g (inc. batteries)	142g (inc. batteries)	145g	226g	136g
Dimensions
(W x H x D)	60x23x115mm	Same as proposed device	105x68x28mm	105x68x28mm	2.5" x 5.25" x 1.0"	1.26" x 3.3" x 4.5"	95x64x30mm
Frequency/
Phase Duration of
program with highest
output power.	Program 7
99Hz
$300\mu S$	Program 1
50Hz
$400 \mu S$	Program 3
99 Hz
$150\mu S$	Program 3
50Hz
$400 \mu S$	Program A
100HZ
$350\mu S$	Custom User 2
150Hz
$400\mu S$	100Hz
$640\mu S$
Baseline to Peak
Current	$80mA @ 500\Omega$
$28mA @ 2k\Omega$
$3.9mA @ 10k\Omega$	$80mA @ 500\Omega$
$28mA @ 2k\Omega$
$3.9mA @ 10k\Omega$	$75mA @ 500\Omega +/- 10%$
$35mA @ 2k\Omega$
$7mA @ 10k\Omega$	$75mA @ 500\Omega +/- 10%$
$35mA @ 2k\Omega$
$7mA @ 10k\Omega$	$60mA @ 500\Omega$	$100mA @ 500\Omega$	$24mA @ 500\Omega$
Baseline to Peak
Output Voltage	$40.0V @ 500\Omega$
$55.6V @ 2k\Omega$
$39.3V @ 10k\Omega$	$40.0V at 500 \Omega$
$55.6V @ 2k \Omega$
$39.3V at 10k \Omega$	$37V @ 500\Omega$
$70V @ 2k\Omega$
$70V @ 10k\Omega$	$37V @ 500\Omega$
$70V @ 2k\Omega$
$70V @ 10k\Omega$	$30V @ 500\Omega$	$50V @ 500\Omega$	$12V 500\Omega$
Maximum RMS Output
Voltage
(+/-10%) Vrms	$9.3 V @ 500 \Omega$
$17.1V @ 2k\Omega$
$14.1V @ 10k\Omega$	$9.15V@ 500\Omega$
$10.74V @ 2k\Omega$
$5.65V @ 10k \Omega$	$6.4 V @ 500\Omega$
$12.1V @ 2k\Omega$
$7 V @ 10k\Omega$	$7.5V @ 500\Omega$
$14 @ 2k\Omega$
$7 V @ 10k\Omega$	$8.85V @ 500\Omega$	$10.5V @ 500\Omega$	4.3V
Estimated assuming a
square pulse shape
0.64ms
Maximum RMS Output
Current
(+/-10%) Irms	$18.6 mA@ 500 \Omega$
$8.6 mA@ 2k\Omega$
$1420 \mu A@ 10k\Omega$	$18.3mA@ 500\Omega$
$5.37mA @ 2k\Omega$
$565\mu A @ 10k\Omega$	$12.8mA @ 500\Omega$
$6.1mA @ 2k\Omega$
$700\mu A @ 10k\Omega$	$15mA @ 500\Omega$
$7 mA @ 2k\Omega$
$490\mu A@ 10k\Omega$	$15.9mA @ 500\Omega$	$21mA @ 500\Omega$
(As
stated in device IFU,
however is inconsistent
with other stated
parameters)	8.6mA
Pulse Width	$640 \mu s$ sum of both
phases $300\mu s$ +40 $\mu s$
interphase interval	$840\mu s$ (both phases max
$400\mu s$ with interphase
interval of $40\mu S$ )	$300\mu S$ ( sum of both
phases; $150\mu S$ ) (Prog 1)	$800\mu S$ sum of both
phases; $400\mu S$ ) (Prog	$700\mu S$ - sum of both
phases; $350\mu S$
(Prog A)	$1200\mu S$ . sum of both
phases and
interphase interval	$640 \mu S$
Net Charge
( $\mu C$ per pulse)	$0\mu C @ 500\Omega$	$0\mu C @ 500\Omega$	$0\mu C @ 500\Omega$	$0\mu C @ 500\Omega$	$0\mu C @ 500\Omega$	$