SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES

K011913 · Sun-Rain System Corp. · IPF · Oct 26, 2001 · Physical Medicine

Device Facts

• Record ID: K011913
• Device Name: SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
• Applicant: Sun-Rain System Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 26, 2001
• 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

Sun-Tens Palm Type R5/Compact Wireless M2 EMS Series is a powered muscle stimulator. Device applies electrical current to electrodes placed on patient's skin. Used for muscle spasm relaxation, disuse atrophy prevention, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, and range of motion maintenance. Operated under medical supervision as adjunctive therapy. Device provides electrical stimulation to target muscle groups to achieve therapeutic outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator; electrical stimulation via skin electrodes; intended for muscle therapy. Class II device. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring adjunctive therapy for 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}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2001

Sun-Rain System Corporation c/o Mr. Yang Tien-Hising ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, Taipei, Taiwan ROC

Re: K011913

Trade/Device Name: Sun-Tens Palm Type R5/Compact Wireless M2 EMS Series Regulation Number: 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: September 10, 2001 Received: October 9, 2001

Dear Mr. Tien-Hising:

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.

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

Page 2 - Mr. Yang Tien-Hising

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse FDA finding of substantial equivalence of your device to a legally promative notification. The 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 additionally 21 CF 1 F ar 4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 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 Oiner general miormation sturers, 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,

R. Mark N. Millikan

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

1. 1. 1. 1. 1. 1.

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

## SUN-RAIN SYSTEM CORP.

F 8, NO. 125, LANE 235, BAO-CHIAO RD., HSIN-TIEN CITY, TAIPEI, TAIWAN R.O.C. E-MAIL:[e-mail] TEL: [phone] WEB: www.sun-rain.com.tw FAX: [phone]

Page 1 of of 1 -

## Applicant: __ SUN-RAIN SYSTEM CORPORATION_

510(k) Number ( if known): __________________________________________________________________________________________________________________________________________________

Device Name: SUN-TENS PALM TYPE R5 / COMPACT WIRELESS M2 EMS SERIES

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

Concurrence of CDRH, office of Device Evaluation (ODE)

| | <div><span style="text-decoration: overline;">Mark N Millerson</span></div> <div>(Division Sign-Off)</div> |
|--|------------------------------------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------------------------------------|

Division of General, Restorative
and Neurological Devices

| Prescription Use | <div>✓</div> |
|------------------------|--------------|
| ( Per 21 CFR 801.109 ) | |

| 510(k) Number | K011913 |
|---------------------------------|----------------------------|
| OR510(k) Number The-Counter-Use | MNM |
| | ( Optional Format 1-2-96 ) |