LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK

K091317 · Bio-Medical Research, Ltd. · GZJ · Jun 25, 2009 · Neurology

Device Facts

• Record ID: K091317
• Device Name: LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
• Applicant: Bio-Medical Research, Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Jun 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. It is intended for prescription use only.

Device Story

Lumbofix® Conductive Garment is a wearable accessory for transcutaneous electrical nerve stimulation (TENS) devices. It consists of a conductive belt and hook-backed electrodes. The garment secures electrodes in place on the lower back, facilitating consistent contact and correct positioning for patients with chronic or intractable pain. It is intended for prescription use. The device does not generate electrical stimulation itself but acts as an interface between a TENS unit and the patient's skin to deliver therapy. By ensuring proper electrode placement on large or difficult-to-reach areas, it improves the efficiency of TENS therapy, potentially reducing pain for the patient.

Clinical Evidence

No clinical studies were submitted. The device relies on established design principles and substantial equivalence to a previously cleared predicate device.

Technological Characteristics

Conductive garment including a belt and hook-backed electrodes. Designed for use with TENS units. Complies with I.S. EN ISO 13485:2003 quality management standards. No active electronic components; passive interface device.

Indications for Use

Indicated for patients requiring symptomatic relief and management of chronic and intractable pain in the lower back region. Assists in positioning/repositioning electrodes on large or difficult-to-reach lower back areas. Prescription use only.

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

• Baxolve XP Conductive Garment Accessory & Lumbar Support Kit (K082190)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letters "BMR" in a stylized font. The letters are arranged horizontally, with a curved line above and below them. The logo has a textured appearance, as if it were printed on a rough surface. The logo is simple and modern, and it would be suitable for a variety of businesses or organizations.

[phone] Fax: [phone]

# 99121

This 510(k) 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 |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Prepared: | 30th April 2009. |

## 2. Device Name

| Trade Name of Device: | Lumbofix® Conductive Garment, Type 420 Back |
|-----------------------|------------------------------------------------------------|
| Common Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification: | Class II |
| Product Code: | G̀ZJ |

# 3. Identification of Equivalent Legally Marketed Device

| Device Trade Name: | Baxolve XP Conductive Garment Accessory & Lumbar<br>Support Kit |
|--------------------|-----------------------------------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd |
| 510(k) No: | K082190 |

# 4. Description of Device

The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS). It aids in the placement of electrodes and secures them in place. Contents include a conductive belt, a pack of hook backed electrodes and instructions for use.

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# 5. Indications for Use

The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. It is intended for prescription use only.

#### 6. Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission.

# 7. Clinical and Non-Clinical Tests

Bio-Medical Research 1.td. ("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. (Slendertone & Neurotech) 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.

No new clinical studies have been submitted as part of this premarket notification. The Lumbofix® Conductive Garment has been CE marked under the EU Medical Device Directive 93/42/EEC (NB No. 0366).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.

#### Public Health Service

# JUN 25 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091317

Trade Name: Lumbofix® Conductive Garment, Type 420 Back Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: April 30, 2009 Received: May 28, 2009

Dear Ms. Keenan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your coetermined the device is substantially equivalent (for the indications forcronood above and in rise enclosure) to legally marketed predicate devices marketed in interstate 101 too surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eoninored prior of ride 2011-11-2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110-) the researce, subject to the general controls provisions of the Act. The r ou may, merelore, maines of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classifical controls. Existing major regulations affecting your device can be finay be subject to cademical Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the over of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Toast of advised that 1 Dris assumes over device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I cacal statuted und regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY art 607); idocing (21 OFR 803); good manufacturing practice requirements as set device-related daverse ovents) (21 CFR Part 820); and if applicable, the electronic form in the quant) systems (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/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,

Keira Alexander for

Malvina B. Evdelman, 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 Statement

510(k) Number (if known):

K091317

Device Name:

Lumbofix® Conductive Garment

Indications for Use:

The Lumbofix® Conductive Garment:

- 『 provides symptomatic relief and management of chronic and intractable pain in the lower back region and
- assists in the frequent and correct positioning and repositioning of pads on difficult to . reach and/or large locations of the lower back.

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)

Dexter 6/24/09

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number ***_***__\$\qquad\$ k091317