MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411

K092793 · Bio-Medical Research, Ltd. · GXY · Dec 7, 2009 · Neurology

Device Facts

• Record ID: K092793
• Device Name: MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
• Applicant: Bio-Medical Research, Ltd.
• Product Code: GXY · Neurology
• Decision Date: Dec 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neurotech Kneehab Conductive Garment and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the quadriceps area of the leg.

Device Story

Kneehab Conductive Garment is an integrated thigh wrap designed for use with Neurotech NMES stimulators. It features internal outlines for positioning four custom adhesive electrodes on the quadriceps. The garment ensures consistent, correct electrode placement for stimulation therapy, simplifying the application process for users. It is intended for use in clinical or home settings. The device does not include a stimulator, battery, or charger; it serves as a conductive interface to facilitate electrical delivery to the muscle tissue. By providing a structured, repeatable mounting system, it improves the accuracy of electrode positioning, potentially enhancing the efficacy of NMES treatment for the quadriceps.

Clinical Evidence

No clinical or non-clinical tests were performed to support substantial equivalence.

Technological Characteristics

Integrated thigh wrap garment; conductive interface for NMES; includes four custom adhesive electrodes; designed for use with external Neurotech stimulators; washable; non-sterile.

Indications for Use

Indicated for patients requiring neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the leg, specifically to assist in the accurate and repeatable placement of electrodes for stimulation.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Kneehab XP Conductive Garment, Type 411 (K083105)
• Lumbofix™ Conductive Garment (K091317)

Submission Summary (Full Text)

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kug2793

Image /page/0/Picture/1 description: The image shows a logo with the letters "BMR" in a bold, sans-serif font. A stylized, curved shape resembling a bracket or parenthesis is positioned to the left of the letters, partially enclosing the "B". The logo has a slightly distressed or textured appearance, giving it a somewhat vintage or worn look. The overall design is simple and impactful, with a focus on the bold letters and the unique curved element.

# I Research Ltd.

Parkmore Business Park West, Galway, Ireland

Tel: [phone] - Fax: [phone]

This summary is being submitted in accordance with the requirements of 21 CFR 807.92.

### 1. Contact Details

DEC - 7 2009

| Name: | Anne-Marie Keenan. |
|------------|-------------------------------------------------------------------------------|
| Address: | Bio-Medical Research Ltd.,<br>Parkmore Business Park, West<br>Galway, Ireland |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Prepared: | 20th November 2009 |

#### 2. Device Name

| Trade Name of Device: | Kneehab Conductive Garment |
|-----------------------|----------------------------|
| Common Name: | Conductive Garment |
| Classification Name: | Cutaneous Electrode |
| Regulation Number: | 21 CFR 882.1320 |
| Product Code: | GXY |

## 3. Identification of Equivalent Legally Marketed Device

| Name: | Kneehab XP Conductive Garment, Type 411 |
|---------------|-----------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K083105 |
| Name: | Lumbofix™ Conductive Garment |
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K091317 |

#### 4. Description of Device

The proposed Kneehab XP Conductive Garment is an integrated thigh wrap garment designed to be used in conjunction with a Neurotech stimulator and custom electrodes for the application of neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the

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thigh. The garment is supplied with a set of four custom designed adhesive pads which may positioned on the inner garment outlines according to fit of the user. Instructions are provided in the user instructions for correct electrode placement. 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/Indications for Use

The Neurotech Kneehab XP Conductive Garment and associated accessories are indicated for use with Neurotech stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the quadriceps area of the leg.

#### 6. Technological Characteristics

This submission differs from the Kneehab XP cleared under K083105 in that it is not packaged with the battery pack, charger or a control unit.

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

No clinical or non clinical tests were performed to support substantial equivalence.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Bio-Medical Research Ltd. c/o Ms. Anne-Marie Keenan Quality/Regulatory Engineer Parkmore Business Park West Galway, Ireland -

DEC - 7 2009

Re: K092793

Trade/Device Name: Kneehab XP Conductive Garment, Model 411 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: September 3, 2009 Received: September 11, 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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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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander Jr.

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):

0927923

Device Name:

Kneehab XP Conductive Garment

Indications for Use:

The Neurotech Kneehab Conductive Garment and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the quadriceps area of the leg.

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 K092793