MEDS-3 NEUROMUSCULAR STIMULATOR

K023446 · Medical Equipment Device Specialists · IPF · Jan 13, 2003 · Physical Medicine

Device Facts

• Record ID: K023446
• Device Name: MEDS-3 NEUROMUSCULAR STIMULATOR
• Applicant: Medical Equipment Device Specialists
• Product Code: IPF · Physical Medicine
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Relaxation of muscle spasms 1. 2. Prevention or retardation of disuse atrophy Increasing local blood circulation 3 . Muscle re-education 4 . Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis Maintaining or increasing range of motion 6.

Device Story

MEDS-3 Neuromuscular Stimulator; powered muscle stimulator; delivers electrical stimulation to muscles; used for therapeutic purposes including spasm relaxation, atrophy prevention, blood circulation, muscle re-education, and post-surgical thrombosis prevention; operated by healthcare professionals; device provides electrical output to patient tissues; clinical benefit derived from muscle stimulation and physiological effects on circulation and muscle tone.

Clinical Evidence

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

Technological Characteristics

Powered muscle stimulator; electrical stimulation output; class II device; product code IPF; regulation 890.5850.

Indications for Use

Indicated for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical calf muscle stimulation to prevent venous thrombosis, and maintaining/increasing range of motion.

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

JAN 1 3 2003

Mr. Darrel Blomberg President Medical Equipment Device Specialists 32158 Camino Capistrano, Suite A-416 San Juan Capistrano, CA 92675

Re: K023446

Trade/Device Name: MEDS-3 Neuromuscular Stimulator Regulation Number: 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: October 11, 2002 Received: October 15, 2002

Dear Mr.Blomberg:

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. Darrel Blomberg

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Mark N Milbern

Celia 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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MEDS-3 NEUROMUSCULAR STIMULATOR 1027446 (510 (k) #_ )

## INDICATIONS FOR USE

THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

- Relaxation of muscle spasms 1.
- 2. Prevention or retardation of disuse atrophy
- Increasing local blood circulation 3 .
- Muscle re-education 4 .
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.

Mark N Millen

Division Sign-Division of General, Restorative and Neurological Devices

7106(k) Number K02 3446

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