MS-ONE, MODEL MS-1

K994065 · Home Wellness West · IPF · Apr 4, 2000 · Physical Medicine

Device Facts

• Record ID: K994065
• Device Name: MS-ONE, MODEL MS-1
• Applicant: Home Wellness West
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 4, 2000
• 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 of retardation of disuse atrophy 3. Increasing local blood circulation এ . Muscle re-education Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis 6. Maintaining or increasing range of motion

Device Story

MS-One is a powered muscle stimulator. Device delivers electrical impulses to muscles to induce contraction. Used for muscle spasm relaxation, atrophy prevention, blood circulation, re-education, post-surgical venous thrombosis prevention, and range of motion maintenance. Operated by clinicians or patients in clinical or home settings. Output consists of electrical stimulation pulses applied via electrodes. Healthcare providers use device to manage musculoskeletal and post-surgical recovery. Benefits include improved muscle function, circulation, and reduced risk of post-surgical complications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator. Electrical stimulation principle. Class II device. Technical specifications and material standards not detailed in provided documentation.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance or increase of 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 APR

Richard M. Harris President Home Wellness West 9393 Activity Road, Suite F San Diego, California 92126

Re: K994065 Trade Name: MS-One (MS-1) Regulatory Class: II Product Code: 89 IPF Dated: March 7, 2000 Received: March 7, 2000

Dear Mr. Harris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosures) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: This response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Richard M. Harris

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

R. Lochner

J Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MS-ONE

(510(k) # K994065)

## INDICATIONS FOR USE

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

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

Duhne R. Vochmer

f General Restorative Devices 510(k) Number K99406