Who is the manufacturer of KNEEHAB XP?

Bio-Medical Research, Ltd. filed the 510(k) submission for KNEEHAB XP (K110350).

What is the FDA product code for KNEEHAB XP?

GZJ. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for KNEEHAB XP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KNEEHAB XP?

Kneehab XP Conductive Garment, Type 411 (K083105); MediStim XP, Type 281 (K082011); MediTens XP, Type 458 (K082011); Staodyn Max Preset (K061516); 300 PV Complete Electrotherapy System (K021100); Bionicare® Stimulator System (K971437).

Who can help prepare an FDA 510(k) submission like KNEEHAB XP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KNEEHAB XP

K110350 · Bio-Medical Research, Ltd. · GZJ · Aug 3, 2011 · Neurology

Device Facts

Record ID	K110350
Device Name	KNEEHAB XP
Applicant	Bio-Medical Research, Ltd.
Product Code	GZJ · Neurology
Decision Date	Aug 3, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Kneehab XP is intended to provide transcutaneous Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).

Device Story

Kneehab XP is a portable, battery-operated combination device providing NMES and TENS. It utilizes 'multipath' technology via a conductive garment fastened around the thigh and above the kneecap to deliver focused NMES muscle contractions. The system includes a rechargeable control unit, garment, custom adhesive electrodes, and charger. The device features nine pre-set programs (six NMES, three TENS) with 20-minute durations. It is operated by the patient or clinician to manage pain or facilitate muscle rehabilitation. The control unit is powered by a 3.6V NiMH battery. The healthcare provider selects the appropriate program based on the patient's clinical needs (e.g., post-surgical strengthening or chronic pain management). The device output is delivered through the garment and electrodes, providing electrical stimulation to the peripheral nervous system to induce muscle contraction or modulate pain signals. This aids in muscle re-education, atrophy prevention, and symptomatic pain relief, potentially improving patient mobility and recovery outcomes.

Clinical Evidence

Bench testing only. The device was evaluated for electrical, mechanical, and thermal safety in accordance with IEC 60601-1 and IEC 60601-2-10 standards. Biocompatibility of electrodes was confirmed via reference to previous 510(k) clearances (K000947). No clinical trial data was required or provided for this submission.

Technological Characteristics

Portable, battery-operated (3.6V NiMH) electrotherapy device. Materials: ABS-PA-757 plastic housing; garment fabric (Nylon, Polychloroprene, Polyurethane, Elastane). Output: Regulated current, pulsed symmetrical biphasic rectangular waveform with interphase interval. Connectivity: Standalone, non-networked. Sterilization: N/A. Software: Microprocessor-controlled with 9 pre-set programs. Safety: Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.

Indications for Use

Indicated for NMES (Programs 1-6): maintain/increase range of motion, prevent/retard disuse atrophy, re-educate muscles, early post-surgical quadriceps strengthening, improve post-surgical knee stability, relax muscle spasms, increase local blood circulation. Indicated for TENS (Programs 7-9): symptomatic relief/management of chronic intractable pain, adjunctive treatment for acute post-surgical/post-traumatic pain, relief of pain associated with arthritis, adjunctive therapy for pain/symptoms of knee osteoarthritis.

Regulatory Classification

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.

Predicate Devices

Kneehab XP Conductive Garment, Type 411 (K083105)
MediStim XP, Type 281 (K082011)
MediTens XP, Type 458 (K082011)
Staodyn Max Preset (K061516)
300 PV Complete Electrotherapy System (K021100)
Bionicare® Stimulator System (K971437)

Related Devices

K083105 — KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 · Bio-Medical Research, Ltd. · Jul 24, 2009
K092791 — KNEEHAB XP CONTROLLER, MODEL 411 · Bio-Medical Research, Ltd. · Dec 30, 2009
K024258 — NEUROTECH KNEEHAB · Bio-Medical Research, Ltd. · Mar 4, 2005
K150413 — QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator · Cymedica Orthopedics, Inc. · Apr 2, 2015
K030254 — INTERFERENTIAL STIMULATOR, MODEL RTM1000 · Ryan Telemedicine · Feb 26, 2003

Submission Summary (Full Text)

{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 Page 2 of 10 {2}------------------------------------------------ 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. - 4. 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 - 11. 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 : . -. . : Page 5 of 10 {5}------------------------------------------------ | 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 | | ・ . Page 6 of 10 . {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 | : ・・ : : Page 7 of 10 : {7}------------------------------------------------ | 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 | . ﺮ ﺔ · . Page 8 of 10 . {8}------------------------------------------------ | 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) | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $<20\mu A$ | Not available | | Maximum Phase Charge @500 (+/-20%) | $24 \mu C @ 500\Omega$ | $32.8\mu C$ | $10.5\mu C @ 500\Omega$ | $30 \mu C$ | $21 \mu C @ 500\Omega$ | $40 \mu C$ | $21 \mu C @ 500\Omega$ | | Maximum Current Density @500 $\Omega$ | $=18.6 mA/83 cm^2$ $=0.22 mA/cm^2$ | $0.22 mA/cm2$ | Using 2" square electrode $= 12.8 mA/25 cm^2$ $= 0.5 mA/ cm^2$ | Using 2" square electrode $= 15 mA/25 cm^2$ $= 0.6 mA/ cm^2$ | Using 2" square electrode $=15.9 mA/25 cm^2$ $= 0.64mA/ cm^2$ | Using 2" square electrode $=21 mA/25 cm^2$ $= 0.84mA/ cm^2$ | Using 12 x 9 square electrodes $=8.6 mA/108 cm^2$ $=0.08 mA/cm^2$ | | Maximum Power Density @500 $\Omega$ (using smallest electrode conductive surface area) | Program 7 $2.1mW/cm^2 @ 500\Omega$ | $2.55 mW/cm2$ | $3.3 mW/cm^2$ | $4.5 mW/cm^2$ | $2.9 mW/cm^2$ | $8.8 mW/cm^2$ | $0.34 mW/cm^2$ | | Burst Mode (ie pulse trains) | YES, NMES on off cycle | Yes, NMES on off cycle | Yes, burst mode TENS | Yes, NMES on off cycle | Yes, burst mode TENS | Yes. NMES and TENS modes | Yes | Page 9 of 10 {9}------------------------------------------------ #### 7. Substantial Equivalence Bio-Medical Research Ltd (BMR) has over 30 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. Bio-Medical Research Ltd. complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003, Medical Device Quality Management System for the design. manufacture and distribution of electro-medical devices. Kneehab XP, Type 412/421 device complies with the following international safety standards: - ロ IEC 60601-1 (1998) + A1: 1991, A2: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety - D IEC 60601-1-2 (2001). Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility Requirements & Tests. - ロ IEC 60601-2-10 (1987) + Al: 2001 Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators A risk management plan has been carried out to I.S. EN ISO 14971 2007. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Bio-Medical Research LTD. c/o Anne Marie Keenan Quality/Regulatory Engineer Parkmore Business Park, West Galway Ireland EI Re: K110350 AUG - 3 2011 Trade/Device Name: Kneehab XP, Type 412/421 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, IPF, NYN Dated: June 24, 2011 Received: June 30, 2011 Dear Ms. Keenan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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. {11}------------------------------------------------ Page 2 - Ms. Anne Marie Keenan 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.html 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 yours, Kesia Alexander Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {12}------------------------------------------------ # Indications for Use KI 10350 510(k) Number (if known): Device Name: Kneehab XP, Type 412/421 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 Prescription Use ﺟ (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) Stan Olchov (Division Sien-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K110350

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