SELECT STIM

K020637 · Care Rehab and Orthopaedic · IPF · May 28, 2002 · Physical Medicine

Device Facts

• Record ID: K020637
• Device Name: SELECT STIM
• Applicant: Care Rehab and Orthopaedic
• Product Code: IPF · Physical Medicine
• Decision Date: May 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

- Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical simulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

Device Story

SELECT STIM™ is a portable neuromuscular stimulator (NMS) used for pain control and muscle therapy. Device delivers electrical stimulation to muscles; intended for relaxation of spasms, prevention of disuse atrophy, blood circulation improvement, muscle re-education, post-surgical venous thrombosis prevention, and range of motion maintenance. Operated by clinicians or patients in clinical or home settings. Healthcare providers use device to manage musculoskeletal conditions; output affects patient muscle activity and circulation. Benefits include improved muscle function and reduced risk of post-surgical complications.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Portable neuromuscular stimulator. Electrical stimulation output. Features jacks and cables compliant with FDA performance standards for electrode lead wires and patient cables. Class II device.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation for venous thrombosis prevention, and maintenance or 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.

Predicate Devices

• Ortho Dx (K971542)

Submission Summary (Full Text)

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# MAY 2 8 2002

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## 10 Appendix D: 510 (k) Summary

## 510(k) Summary

| Submitter's Information: | Christian E. Hunt<br>Care Rehab®<br>1124 Dominion Ct<br>McLean, VA 22102 | Phone: [phone]<br>FAX: [phone]. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Date of preparation: | February 26, 2002 | |
| Proprietary Name: | SELECT STIM™ | |
| Common Name: | Neuromuscular Stimulator | |
| Classification Name: | Powered Muscle Stimulator<br>21 CFR 890.5850 | |
| Device Classification: | Class II | |
| Predicate Device: | Ortho Dx (K971542) | |
| Description of Device: | A portable NMS device for pain control. | |
| Intended Use: | - Relaxation of muscle spasms<br>- Prevention or retardation of disuse atrophy<br>- Increasing local blood circulation<br>- Muscle re-education<br>- Immediate post-surgical simulation of calf<br>muscles to prevent venous thrombosis<br>- Maintaining or increasing range of motion | |
| Technological Comparison: | The SELECT STIM™ has technological characteristics that are<br>substantially equivalent to those of the predicate device, as determined<br>by bench testing. It differs technologically only by the use of jacks and<br>cables which comply with FDA's Final Rule "Medical Devices;<br>Establishment of a Performance Standard for Electrode Lead Wires and<br>Patient Cables." | |
| Labeling Comparison: | The labeling of the SELECT STIM™ is substantially equivalent to that of<br>the predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or SELECT<br>STIM™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The SELECT STIM™ is substantially equivalent in electrical output to<br>the predicate device and any differences between the devices do not pose<br>new questions of safety and effectiveness. | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three curved lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 2 8 2002 -

Mr. Christian E. Hunt Care Rehab 1124 Dominion Ct. McLean, VA 22102

Re: K020637

Trade/Device Name: SELECT STIM Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: February 25, 2002 Received: February 27, 2002

Dear Mr. Hunt:

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. This

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Page 2 - Mr. Hunt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. 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,

Mark N. Millenson

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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### Indications for Use 4 20637 510(k) Number: Device Name: SELECT STIM™

### Statement of Indication of Use:

The Select Stim is recommended for use for the following conditions:

- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation 3.
- Muscle re-education 4.
- Immediate post-surgical simulation of calf muscles to prevent venous thrombosis રું.
- Maintaining or increasing range of motion 6.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Milken

Division Sign-Off General, F. Storative

510(k) Number K0200

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