BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294

K023916 · Bio-Medical Research, Ltd. · GZJ · Apr 15, 2004 · Neurology

Device Facts

• Record ID: K023916
• Device Name: BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
• Applicant: Bio-Medical Research, Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Apr 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for: Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and management of chronic lower back pain. Lumbar support.

Device Story

The NeuroTech BackTENS (Type 294) is a self-contained, battery-operated transcutaneous electrical muscle stimulator integrated into a lumbar support belt. It delivers electrical stimulation via adhesive electrodes to provide non-invasive pain relief. The device is intended for over-the-counter use by patients for the management of chronic lower back pain. It features an LCD screen for user interface and includes compliance logging to track therapy usage. The device functions by applying electrical signals to the skin, similar to the predicate Smart-TENS device. The healthcare provider or patient uses the device to manage pain symptoms, with the lumbar support providing physical stabilization while the TENS component provides electrical stimulation.

Clinical Evidence

Bench testing only. The device was evaluated for electrical output performance and compliance with safety and electromagnetic compatibility standards, including IEC 60601-1, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, and EN 55011. Hazard, risk, and failure mode effects analyses were conducted.

Technological Characteristics

Battery-operated transcutaneous electrical nerve stimulator. Integrated into a lumbar support belt with adhesive electrodes. Features an LCD screen for user interface and compliance logging. Complies with IEC 60601-1, IEC 60601-2-10, and various EMC standards (IEC 61000 series, EN 55011).

Indications for Use

Indicated for symptomatic relief and management of chronic lower back pain and provision of lumbar support in patients requiring TENS therapy. Suitable for over-the-counter use.

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

• NeuroTech Smart-TENS, Type 456 (K961376)

Submission Summary (Full Text)

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K023916

Page 1 of 2 510(k) Summary

# APR 1 5 2004

Bio-Medical Research Ltd Parkmore Business Park, West Galway Ireland

| 1 | - | |
|---------------------------|---------|--|
| August of the career<br>I | -<br>11 | |
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| 510 (k) Summary of Safety and Effectiveness. | | | |
|------------------------------------------------------------|---|------------------------------------|--------------------------------------------------------------------------------------------------------|
| This summary is submitted in accordance with 21 CFR 807.92 | | | |
| a) | 1 | Submitted by | Bio-Medical Research Ltd<br>BMR House<br>Parkmore Business Park, West<br>Galway<br>Republic of Ireland |
| Establishment Registration Number | | | 8020867 |
| Contact Person | | | Michelle Sawyer |
| Phone | | | [phone] |
| Fax | | | [phone] |
| e-mail | | | [e-mail] |
| Title | | | Regulatory Affairs Manager |
| Date of Preparation | | | November 2002. |
| 2 | | Trade Name of Device | NeuroTech© BackTENS & Lumbar support Type 294. |
| Common Name | | | NeuroTech© BackTENS & Lumbar support. |
| Classification name | | | Transcutaneous Electrical Nerve Stimulator.(882.5810) |
| 3 | | Identification of predicate device | NeuroTech© Smart-TENS , Type 456, Clearance ref# K961376. |

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#### Description of Device 4

The NeuroTech BackTENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.

The device is intended to provide a non-invasive therapy for over the counter sale.

#### Intended Use ട

The device is indicated for:

- · Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and management of chronic lower back pain.
- · Lumbar support.

## Technological Comparison ട

The NeuroTech BackTENS is similar to the Smart-TENS in it's delivery of the stimulation signal and has similar parameter settings. Both products utilise a LCD screen with user compliance logging.

### Non- clinical Tests 7

Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;

- IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for . safety.
- . IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- IEC 61000-4-2:1995: Electromagnetic compatibility .
- IEC 61000-4-3:1997: Electromagnetic compatibility .
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .

Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.

A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines, resembling a caduceus or a representation of human services. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2004

Carol O'Donnell, Ph.D. Clinical and Regulatory Affairs Manager Bio-Medical Research Limited BMR House Parkmore Business Park West Galway Ireland

Re: K023916

Trade Name: NeuroTech® Back TENS and Lumbar Support, Type 294 Regulation Number: 21 CFR 882.5890, 21 CFR 882.1320, and 21 CFR 890.3490 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Cutaneous electrode, and Truncal orthosis

Regulatory Class: II Product Code: GZJ, GXY, and IQE Dated: January 8, 2004 Received: January 16, 2004

Dear Dr. O'Donnell:

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 such 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 complics 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); 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 - Carol O'Donnell, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and w your finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark A. Mcllussen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):K023916

neurotech BACKTENS & Lumbar Support Device, type 294 Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milham

eral, Restorative, and Neurological Devices

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510(k) Number K023916