APEX MEDICAL DIGITAL EMS TS1311, TS1312

K021754 · Apex Medical Corp. · IPF · Jun 28, 2002 · Physical Medicine

Device Facts

• Record ID: K021754
• Device Name: APEX MEDICAL DIGITAL EMS TS1311, TS1312
• Applicant: Apex Medical Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 28, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apex Medical Digital EMS is intended to be used in: - 1. Relaxation of Muscle Spasm. - 2. Prevention or retardation of disuse atrophy. - 3. Increase local blood circulation. - 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

Apex Medical Digital EMS (models TS1311, TS1312) is a powered muscle stimulator. Device delivers electrical impulses to muscles via electrodes to induce contraction. Used for muscle spasm relaxation, atrophy prevention, circulation improvement, muscle re-education, post-surgical venous thrombosis prevention, and range of motion maintenance. Operated by healthcare professionals or patients under prescription. Device provides therapeutic electrical stimulation; output parameters controlled by user settings. Benefits include improved muscle function and circulation, and reduced risk of post-surgical complications.

Clinical Evidence

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

Technological Characteristics

Powered muscle stimulator (Product Code: IPF). Device utilizes electrical stimulation for muscle contraction. Form factor: digital unit with electrode interface. Class II device under 21 CFR 890.5850.

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, immediate post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance/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)

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2002

Mr. Alan Chang Manager, Research and Development Apex Medical Corporation 10th Floor, No. 31, Lane 169 Kang-Ning St. Shi-Chih, Taipei Hsien Taiwan, R.O.C.

Re: K021754

Trade/Device Name: Apex Medical Digital EMS, models TS1311 and TS1312 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 27, 2002 Received: May 29, 2002

Dear Mr. Chang:

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. Alan Chang

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 vou 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,

A. Scott M. Winter, Ph.D., M.D.

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}------------------------------------------------

Page 1 of 1

021754

510(k) Number :

Device Name : Apex Medical Digital EMS TS1311, TS1312 Indications For Use:

Apex Medical Digital EMS is intended to be used in:

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

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ x (Per 21 CFR 801.109)

OR
Styk Durdis

Over-The-Counter-Use_ (Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number
K021754