CLASSIC NMS

K021905 · Care Rehab, Inc. · IPF · Sep 5, 2002 · Physical Medicine

Device Facts

• Record ID: K021905
• Device Name: CLASSIC NMS
• Applicant: Care Rehab, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 5, 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

CLASSIC NMS™ is a powered muscle stimulator used for therapeutic muscle stimulation. Device delivers electrical output to muscles to achieve clinical goals including spasm relaxation, atrophy prevention, circulation improvement, muscle re-education, and post-surgical thrombosis prevention. Operated by clinicians or patients in clinical or home settings. Output characteristics are electrically equivalent to predicate device. Device utilizes jacks and cables compliant with FDA performance standards for electrode lead wires and patient cables. Benefits include improved muscle function and prevention of post-surgical complications.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing of electrical output characteristics.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850). Electrical stimulation via electrodes. Features jacks and cables compliant with FDA performance standards for electrode lead wires and patient cables. Standalone 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 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.

Predicate Devices

• Ortho Dx (K971542)

Submission Summary (Full Text)

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K021905

### 5 2002 SEP

#### 11 Appendix : 510 (k) Summary

## Christian E. Hunt Submitter's Information: Care Rehab® Phone: [phone] Dominion Ct FAX: [phone]. McLean, VA 22102 June 7, 2002 Date of preparation: CLASSIC NMS™ Proprietary Name: Neuromuscular Stimulator Common Name: Powered Muscular Stimulator Classification Name: 21 CFR 890.5850. Device Classification: Class II Ortho Dx (K971542) Predicate Device: A portable NMS device for pain control. Description of Device: Intended Use: Relaxation of muscle spasms ﺘﻌ Prevention or retardation or 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 -The CLASSIC NMS™ has technological characteristics that are Technological Comparison: substantially equivalent to those of the predicate device, as determined by bench testing. It differs technologically only by the use of jacks and cables which comply with FDA's Fnal Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables." The labeling of the CLASSIC NMS™ is substantially equivalent to that Labeling Comparison: of the predicate device. Bench testing demonstrated that the output characteristics or CLASSIC Nonclinical Testing: NMS™ are substantially equivalent to that of the predicate device. Clinical Testing: Not applicable. The CLASSIC NMS™ is substantially equivalent in electrical output to Conclusions from Testing: the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.

# 510(k) Summary

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Christian E. Hunt President Care Rehab® 1124 Dominion Court McLean, Virginia 22102

Re: K021905

Trade/Device Name: Classic NMSTM Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: June 7, 2002 Received: June 10, 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.

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Page 2 - Mr. Christian 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 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,

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

510(k) Number:

Device Name: CLASSIC NMS™

## Statement of Indication of Use:

The Classic NMS 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 :

1904

- 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)

Division of General, Restorative and Neurological Devices

510(k) Number k021905