HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312

K022998 · Home Care Technology Co., Ltd. · IPF · May 20, 2003 · Physical Medicine

Device Facts

• Record ID: K022998
• Device Name: HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
• Applicant: Home Care Technology Co., Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: - Relaxation of muscle spasms; - Prevention or retardation of disuse atrophy - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion. - Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Device Story

Powered muscle stimulator (models HT-311, HT-311N, HT-312) applies electrical current to electrodes placed on patient skin. Device functions as adjunctive therapy for muscle spasm relaxation, disuse atrophy prevention, muscle re-education, post-surgical venous thrombosis prevention, and range of motion maintenance. Used in clinical settings under medical supervision. Output is electrical stimulation delivered via electrodes to target muscle groups.

Clinical Evidence

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

Technological Characteristics

Powered muscle stimulator; electrical stimulation via skin electrodes; models HT-311, HT-311N, HT-312; class II device (21 CFR 890.5850).

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, muscle re-education, immediate post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance/increase of range of motion. Must be used under medical supervision.

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Public Health Service

MAY 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Home Care Technology Co., Ltd. c/o Mr. Shu-Chen Cheng ROC Chinese-European Industrial Research Society 2064 Tamarin Drive Columbus, OH 43235

Re: K022998

Trade/Device Name: Home Care Various Models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: April 9, 2003 Received: April 14, 2003

Dear Mr. Cheng:

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

{1}------------------------------------------------

Page 2 - Mr. Shu-Chen Cheng

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. 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. McKenna

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

{2}------------------------------------------------

## 4. INDICATIONS FOR USE STATEMENT

Applicant:

510(k) Number:____IO BE ASSIGNED___________

K 022998

## Device Name : Home Care various models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312

## Indications for Use :

- Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy
- Muscle re-education

- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use | | | Over-The-Counter | |
|--------------------|--|--|--------------------------|--|
| Per 21 CFR 801,109 | | | (Optional Format 1-2-96) | |

OR
Mark N. Millerson

| | (Division Sign-Off) | | | |
|---------------|----------------------------------|--|--|--|
| | Division of General, Restorative | | | |
| | and Neurological Devices | | | |
| 510(k) Number | K022998 | | | |