ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1

K031427 · Biomedical Life Systems, Inc. · IPF · Aug 19, 2003 · Physical Medicine

Device Facts

• Record ID: K031427
• Device Name: ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
• Applicant: Biomedical Life Systems, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; 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.

Device Story

Electrical Neuromuscular Stimulator (Model BMLS03-1) provides external electrical stimulation via biphasic output. Device used as therapeutic adjunct for muscle reeducation, atrophy prevention, spasm relaxation, range of motion maintenance, circulation improvement, and postsurgical venous thrombosis prevention. Operated by clinicians or patients in clinical or home settings. Device delivers electrical pulses to muscles; output parameters controlled by user to achieve therapeutic goals. Benefits include improved muscle function and circulation, and reduced risk of post-operative complications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850, Product Code IPF). Delivers biphasic electrical output for neuromuscular stimulation. Standalone device.

Indications for Use

Indicated for patients requiring therapeutic adjunct for muscle disuse atrophy prevention/retardation, muscle spasm relaxation, muscle reeducation, range of motion maintenance/increase, local blood circulation increase, and immediate postsurgical calf muscle stimulation to prevent venous thrombosis.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2003

Mr. Richard Saxon President BioMedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360

Re: K031427

Trade/Device Name: (EMS) Electrical Neuromuscular Stimulator Model BMLS03-1 Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Codes: IPF Dated: April 28, 2003 Received: May 21, 2003

Dear Mr. Saxon:

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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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,

sincerely yours,

Mark A. Mellema

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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510(k) Number (if known):

Device Name:

(EMS) Electrical Neuromuscular Stimulator For Muscle Reeducation - Class II Model BMLS03-1

Indications for Use: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; 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.

031427

for Mark A. Millman

Division of General, Restorative and Neurological Devices

510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)