HMS-DHR-3 NEUROMUSCULAR STIMULATOR

K021472 · Home Medical Services · IPF · Aug 6, 2002 · Physical Medicine

Device Facts

• Record ID: K021472
• Device Name: HMS-DHR-3 NEUROMUSCULAR STIMULATOR
• Applicant: Home Medical Services
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

HMS-DHR-3 Neuromuscular Stimulator is a powered muscle stimulator used to deliver electrical stimulation to muscles. Device operates by applying electrical impulses to induce muscle contraction or relaxation. Used in clinical settings or home environments under physician guidance. Healthcare providers use device to manage muscle atrophy, improve circulation, re-educate muscles, and prevent post-surgical venous thrombosis. Output affects clinical decision-making by providing therapeutic muscle stimulation to aid patient recovery and mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850, Product Code IPF). Device functions via electrical stimulation for neuromuscular application.

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

## AUG 0 6 2002

C. A. Teklinski Home Medical Services 9393 Activity Road. Suite F San Diego, California 92126

> K021472 Trade/Device Name: HMS-DHR-3 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: May 6, 2002 Received: May 8, 2002

Dear Mr. Teklinski:

Re:

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 (OS) regulation (21 CFR Part 820); and if

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Page 2 -- C. A. Teklinski

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 and additionally 21 CFR Part 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" (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. Millican

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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# HMS-DHR-3 NEUROMUSCULAR STIMULATOR

### 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.
- Prevention or retardation of disuse atrophy 2.

#

(510 (k)

- Increasing local blood circulation 3.
- 4 . Muscle re-education
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 6. Maintaining or increasing range of motion

Mark N Millican

Division Sign T) ision of General, Restorative and Neurological Devi

510(k) Number.

## 000107