CARE STIM

K022417 · Care Rehab and Orthopaedic · GZJ · Apr 10, 2003 · Neurology

Device Facts

• Record ID: K022417
• Device Name: CARE STIM
• Applicant: Care Rehab and Orthopaedic
• Product Code: GZJ · Neurology
• Decision Date: Apr 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Classic Stim is recommended for use for the following conditions: • 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

CARE STIM™ is a portable neuromuscular stimulator (NMS) used for muscle re-education and therapeutic stimulation. Device delivers electrical output to muscles to induce contraction; intended for relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, post-surgical calf muscle stimulation to prevent venous thrombosis, and maintaining/increasing range of motion. Operated by clinicians or patients in clinical or home settings. Output affects muscle activity directly to achieve therapeutic goals. Benefits include improved muscle function and circulation, and prevention of complications like venous thrombosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable NMS device. Electrical output characteristics are substantially equivalent to the predicate device. Class II device under 21 CFR 890.5850.

Indications for Use

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

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.

Predicate Devices

• Ortho Dx

Submission Summary (Full Text)

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KO 22417

## 12 Appendix F: 510 (k) Summary

## APR 1 0 2003

## 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: | July 23, 2002 | |
| Proprietary Name: | CARE STIM™ | |
| Common Name: | Muscle Stimulator | |
| Classification Name: | Powered Muscle Stimulator<br>21 CFR 890.5850. | |
| Device Classification: | Class II | |
| Predicate Device: | Ortho Dx | |
| Description of Device: | A portable NMS device for muscle re-education. | |
| Intended Use: | The Classic Stim is recommended for use for the following conditions:<br>• 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 muscles to prevent venous<br>thrombosis<br>• Maintaining or increasing range of motion | |
| Technological Comparison: | The CARE STIM™ has technological characteristics that are<br>substantially equivalent to those of the predicate device, as determined<br>by bench testing. | |
| Labeling Comparison: | The labeling of the CARE STIM™ is substantially equivalent to that of the<br>predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARE<br>STIM™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE STIM™ is substantially equivalent in electrical output to the<br>predicate device and any differences between the devices do not pose new<br>questions of safety and effectiveness. | |

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APR 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christian E. Hunt President Care Rehab and Orthopaedic 1124 Dominion Court McLean, Virginia 22102

Re: K022417

Trade Name: Care™ Stim Regulation Number: 21 CFR 890.5380 Regulation Name: Powered Exercise Equipment Regulatory Class: II Product Code: GZJ Dated: January 9, 2003 Received: January 13, 2003

Dear Mr. Hunt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 -- Mr. Christian E. Hunt

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,

for Mark N. Mikkelsen

elia 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

510(k) Number:

Device Name: CARE STIM1M

Statement of Indication of Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milken

Division Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K022417

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