MODEL GST-1

K040193 · Medical Equipment Device Specialists · GZJ · Apr 27, 2004 · Neurology

Device Facts

• Record ID: K040193
• Device Name: MODEL GST-1
• Applicant: Medical Equipment Device Specialists
• Product Code: GZJ · Neurology
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AS A POWERED MUSCLE STIMULATOR 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing 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 AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR 1. Symptomatic relief of chronic intractable pain

Device Story

GST-1 is a dual-function electrical stimulator; operates as both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). Device delivers electrical impulses via electrodes to patient skin; intended for clinical or home use under prescription. PMS function targets muscle tissue for spasm relaxation, atrophy prevention, circulation improvement, re-education, post-surgical thrombosis prevention, and range of motion maintenance. TENS function targets nerves for symptomatic relief of chronic intractable pain. Healthcare providers prescribe device; patients typically self-administer therapy using device controls. Output affects muscle contraction or nerve signaling to manage pain and physical rehabilitation needs.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Electrical stimulator; dual-mode (TENS and PMS). Regulated under 21 CFR 882.5890 and 21 CFR 890.5850. Product codes GZJ and IPF. Device utilizes electrical output for nerve and muscle stimulation.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, maintenance/increase of range of motion, or symptomatic relief of chronic intractable pain.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Mr. C. A. Teklinski Medical Equipment Device Specialists 9811 W. Charleston Suite 2387 Las Vegas. Nevada 89117

Re: K040193 Trade/Device Name: GST-1 Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator Regulatory Class: II Product Code: GZJ, IPF Dated: January 20, 2004 Received: January 28, 2004

Dear Mr. Teklinski:

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 adultcration.

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); labcling (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. C. A. Teklinski

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,

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

## INDICATIONS FOR USE

THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

## AS A POWERED MUSCLE STIMULATOR

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

## AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

- 1 . Symptomatic relief of chronic intractable pain
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

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

510(3) Number K040193 - 510(k) Number

> X Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

000105