ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1

K061476 · Biomedical Life Systems, Inc. · GZJ · Jul 26, 2006 · Neurology

Device Facts

• Record ID: K061476
• Device Name: ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
• Applicant: Biomedical Life Systems, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jul 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Device Story

TENS device Model BMLS06-1 provides electrical stimulation for pain management; intended for symptomatic relief of chronic intractable pain and adjunctive treatment of post-surgical/post-traumatic acute pain. Device delivers electrical pulses via electrodes to patient; operates as a TENS unit for pain modulation. Used in clinical or home settings under prescription. Healthcare providers or patients use device to manage pain symptoms; output affects patient comfort and pain perception.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Transcutaneous electrical nerve stimulator; Class II device (21 CFR 882.5890); product code GZJ. Electrical stimulation output for pain relief.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain and as adjunctive treatment for post-surgical and post-traumatic acute pain.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 26 2006

BioMedical Life Systems % Mr. Gary Bussett P.O. Box 1360 Vista, California 92085

Re: K061476

Trade/Device Name: (TENS) Transcutaneous Electrical Nerve Stimulator for Pain Relief Model BMLS06-1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 30, 2006 Received: May 30, 2006

Dear Mr. Bussett:

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 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): 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 - Mr. Gary Bussett

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 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,

Hulbert Lemmens

Mark N. Melkerson 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): K061476

Device Name:

(TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS06-1

Indications For Use: Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Prescription Use × (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 IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Off)
Division of General Restor

Division of General, Restorat and Neurological Devices

510(k) Number K061176