COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1

K041388 · Biomedical Life Systems, Inc. · GZJ · Nov 23, 2004 · Neurology

Device Facts

• Record ID: K041388
• Device Name: COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
• Applicant: Biomedical Life Systems, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. TENS Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Story

Combination device (Model BMLS04-1) provides three modalities: neuromuscular electrical stimulation (NMES), interferential stimulation (IFC), and transcutaneous electrical nerve stimulation (TENS). Device delivers electrical pulses to patient via electrodes. NMES mode targets muscle atrophy, reeducation, range of motion, and circulation; IFC and TENS modes target pain management. Operated by clinicians or patients (prescription use). Device output parameters (frequency, pulse width, intensity) are adjusted to achieve therapeutic goals. Benefits include pain relief, muscle function maintenance, and venous thrombosis prevention.

Clinical Evidence

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

Technological Characteristics

Combination electrical stimulator providing NMES, IFC, and TENS modalities. Uses biphasic electrical output. Device is a portable electronic unit. No specific materials, software architecture, or connectivity details provided.

Indications for Use

Indicated for patients requiring muscle stimulation for atrophy prevention, muscle reeducation, range of motion maintenance, blood circulation improvement, or postsurgical calf stimulation to prevent venous thrombosis; also indicated for symptomatic relief and management of chronic, post-surgical, or 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

NOV 2 3 2004

Mr. Gary Bussett Biomedical Life Systems, Inc. 2448 Cades Way P.O. Box 1360 Vista, California 92085

Re: K041388

K041300
Trade/Device Name: Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BML \$04-1

Regulation Numbers: 21 CFR 890.5850, 882.5890

Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain, and inferential current stimulator.

Regulatory Class: II Product Code: GZJ, IPF, LIH Dated: November 12, 2004 Received: November 15, 2004

Dear Mr. Bussett:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass barearon to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the reserved 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

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## Page 2 - Mr. Gary Bussett

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.

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/dsma/dsmamain.html

Sincerely yours,

Mark N. Mellauson

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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number : K041388

Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Device Name: Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1

Indications for Use:

Muscle Stimulator Mode:

External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

## Interferential Mode:

Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.

## TENS Mode:

Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21CFR807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation

Mad. A. Milluson

. Restorative,

510(k) Number K041388