TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR

K031310 · Tai Sheng Electrical Machinery Co., Ltd. · IPF · Apr 12, 2004 · Physical Medicine

Device Facts

• Record ID: K031310
• Device Name: TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR
• Applicant: Tai Sheng Electrical Machinery Co., Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 12, 2004
• 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 pation's skin to function as: Relaxation of muscle spasms; Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical discases and conditions.

Device Story

Powered muscle stimulator (TS-L166) applies electrical current to patient skin via electrodes; functions to relax muscle spasms. Used in clinical settings under medical supervision as adjunctive therapy for medical conditions. Device delivers electrical stimulation to target muscle groups to achieve therapeutic relaxation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator; electrical stimulation via skin electrodes; Class II device; 21 CFR 890.5850.

Indications for Use

Indicated for patients requiring adjunctive therapy for muscle spasm relaxation. Must be used under medical supervision for treatment of medical diseases and conditions.

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

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APR 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TAI Sheng Electrical Machinery Co., C/o: Dr. Jen, Ke-Min R.O.C. Chinesc-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Rc: K031310

Trade/Device Name: TAI SHENG Powered Muscle Stimulator, TS-L166 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: February 17, 2004 Received: February 25, 2004

Dear Dr. Jen, Ke-Min:

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.

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Page 2 - Dr. Jen, Ke-Min

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,

Mark A. McMillan

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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## 4. INDICATIONS FOR USE STATEMENT

Applicant : 510(k) Number : Device Name: TAI SHENG Powered Muscle Stimulator, TS-L166

## Indications for Use :

- . Specific indications: used to apply an electrical current to electrodes on pation's . skin to function as:
Relaxation of muscle spasms;

- Clinical settings: The device should only be used under medical supervisions for . adjunctive therapy for the treatment of medical discases and conditions.
(PLFASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence Vice Evaluation (ODE) Division of General, Restorative, and Neurological Devices 631310 510(k) Number_ X Prescription Use OR Over-The-Counter Per 21 CFR 801.109 (Optional Format 1-2-96)