KNEEHAB XP CONTROLLER, MODEL 411

K092791 · Bio-Medical Research, Ltd. · IPF · Dec 30, 2009 · Physical Medicine

Device Facts

• Record ID: K092791
• Device Name: KNEEHAB XP CONTROLLER, MODEL 411
• Applicant: Bio-Medical Research, Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kneehab XP Controller applies muscle and nerve stimulation by using the principles of Neuromuscular Electrical Nerve Stimulation (NMES). NMES is 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. The Kneehab XP Controller is indicated for muscle re-education of the quadriceps, maintaining or increasing 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 and increasing local blood circulation.

Device Story

Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator (NMES). It utilizes multipath technology to deliver constant current pulses to quadriceps nerves via a conductive garment and electrodes. Device is powered by a 3.6V NiMH rechargeable battery. It features three 20-minute treatment programs. Used in clinical or home settings to induce quadriceps contractions. Healthcare providers or patients use the device to facilitate muscle re-education, prevent atrophy, and improve post-surgical stability. Output is electrical stimulation; clinical benefit includes improved muscle strength, joint range of motion, and local blood circulation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety and electromagnetic compatibility (EMC) testing per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards.

Technological Characteristics

Portable two-channel NMES stimulator; constant current pulse output; 3.6V NiMH rechargeable battery; custom single-connector interface for garment/charger; over-molded internal connections for moisture protection. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.

Indications for Use

Indicated for quadriceps muscle re-education, maintaining/increasing knee joint range of motion, preventing/retarding quadriceps disuse atrophy, early post-surgical quadriceps strengthening, improving post-surgical knee stability, and increasing local blood circulation.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Kneehab XP Conductive Garment, Type 411 (K083105)

Submission Summary (Full Text)

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(0)91 774300

This 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.,<br>Parkmore Business Park, West<br>Galway, Ireland | DEC 30 2009 |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| E-Mail: | [e-mail] | |
| Prepared: | 3rd September 2009 | |

### 2. Device Name

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| Trade Name of Device: | Kneehab XP Controller (Type 411) |
|-----------------------|----------------------------------|
| Common Name: | Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code: | IPF |

## 3. Identification of Equivalent Legally Marketed Device

| Name: | Kneehab XP Conductive Garment, Type 411 |
|---------------|-----------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K083105 |

#### 4. Description of Device

· The Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. It is designed to work in conjunction with the Kneehab XP. Conductive Garment and electrodes to deliver highly focused and accurate quadriceps contractions by using constant current pulses to stimulate the nerves in the quadriceps area of the body.

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The Kneehab XP controller is supplied with a rechargeable control unit, battery charger and instructions for use. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. The controller may be only be connected to the garment/electrodes or the charger due to the utilisation of a single custom connector. All the internal connections of the unit are over-molded to prevent moisture ingress. There are three treatment programs in total with duration of 20 minutes each and details of these are included in the instructions for use.

### 5. Statement of Intended Use/Indications for Use

The Kneehab XP Controller applies muscle and nerve stimulation by using the principles of Neuromuscular Electrical Nerve Stimulation (NMES). NMES is 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.

The Kneehab XP Controller is indicated for muscle re-education of the quadriceps, maintaining or increasing 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 and increasing local blood circulation.

#### 6. Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Kneehab XP Controller, Type 411 device. The Kneehab XP Controller is substantially equivalent to the predicate device Kneehab XP Conductive Garment cleared under K083105.

#### 7. Clinical and Non-Clinical Tests

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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. BMR has two divisions - Slendertone, which develops and markets a range of consumer health and fitness products and Neurotech, which provides a range of neuromuscular stimulators for pain management and rehabilitation. 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.

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The Kneehab XP Controller, Type 411 unit complies with the following electrical safety and EMC international standards:

- O IEC 60601-1 (1998) + A1: 1991, A2: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety
- IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility Requirements & Tests.
- D IEC 60601-2-10 (1987) + A1: 2001 Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle, with three curved lines representing its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Bio-Medical Research Ltd., % Ms. Anne-Marie Keenan Parkmore Business Park, West Galway, Ireland

Re: K092791

Trade/Device Name: Kneehab XP Controller, Type 411 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF DEC 30 2009 Dated: November 25, 2009 Received: December 2, 2009

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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.

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Page 2 - Ms. Anne-Marie Keenan

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krane

C Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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:

Kneehab XP Controller, Type 411

Indications for Use:

- 트 Muscle re-education of the quadriceps,
- 트 Maintaining or increase range of motion of the knee joint,
- 트 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. 사

Prescription Use X (Part 21 CFR 801 Subpart D)

: >

Over-The-Counter Use AND/OR (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)

FOR M.MELKERSON

(Division Sign-Off), Division of Surgical, Orthopedic, and Restorative Devices

K092791 510(k) Number _