HMS NEUROMUSCULAR STIMULATOR

K994062 · Home Medical Services, Inc. · IPF · Apr 10, 2000 · Physical Medicine

Device Facts

• Record ID: K994062
• Device Name: HMS NEUROMUSCULAR STIMULATOR
• Applicant: Home Medical Services, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The HMS Neuromuscular Stimulator (Model HMS-3) is a powered muscle stimulator used to deliver electrical stimulation to muscles. It is intended for clinical or home use to manage muscle-related conditions, including spasms, atrophy, and circulation issues, as well as post-surgical venous thrombosis prevention. The device operates by applying electrical pulses to the target muscle groups, which induces contraction or relaxation as required for therapy. Healthcare providers or patients use the device to facilitate muscle re-education and maintain range of motion. The output consists of controlled electrical stimulation, which directly affects muscle activity to achieve the stated therapeutic goals.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Powered muscle stimulator; electrical stimulation output; intended for muscle spasm relaxation, atrophy prevention, circulation, re-education, and range of motion maintenance.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, immediate 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing the staff and two wavy lines representing the snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2000

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

Re: K994062

> Trade Name: HMS Neuromuscular Stimulator, Model HMS-3 Regulatory Class: II Product Code: 89 IPF Dated: March 3, 2000 Received: March 6, 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/dsmamain.html".

Sincerely yours,

Donna R. Lochner.

- A 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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## HMS NEUROMUSCULAR STIMULATOR

(510(k) # K994062)

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

s D. Lochner.

General Restorative Devices 510(k) Number K 1940 G Z