CARE ETS

K023036 · Care Rehab and Orthopaedic · IPF · Jun 19, 2003 · Physical Medicine

Device Facts

• Record ID: K023036
• Device Name: CARE ETS
• Applicant: Care Rehab and Orthopaedic
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Care ETS 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 • Stroke Rehabilitation , using muscle re-education techniques • Maintaining or increasing range of motion

Device Story

Portable neuromuscular stimulator (NMS) with EMG-triggered functionality; used for muscle re-education and rehabilitation. Device detects EMG signals from patient muscles; processes signals to trigger electrical stimulation; provides output via electrodes to stimulate muscle tissue. Used in clinical or home settings under professional guidance. Healthcare providers use output to facilitate muscle contraction, prevent atrophy, and improve range of motion. Benefits include improved circulation, reduced spasms, and post-surgical thrombosis prevention.

Clinical Evidence

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

Technological Characteristics

Portable powered muscle stimulator; EMG-triggered; Class II device. Operates as a neuromuscular stimulator (NMS) and biofeedback device. Electrical output characteristics verified via bench testing. Connectivity and specific materials not detailed.

Indications for Use

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

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

• Automove AM800 (K972997)

Submission Summary (Full Text)

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K023036

## Appendix J: 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: | March 20, 2003 | |
| Proprietary Name: | CARE ETS™ | |
| Common Name: | Neuromuscular Stimulator ( EMG Triggered) | |
| Classification Name: | Powered Muscle Stimulator<br>21 CFR 890.5850. | |
| Panel Code: | 89 | |
| Product Code: | IPF | |
| Device Classification: | Class II | |
| Predicate Device: | Automove AM800 (K972997) | |
| Description of Device: | A portable NMS device for muscle re-education. | |
| Intended Use: | The Care ETS 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>• Stroke Rehabilitation , using muscle re-education techniques<br>• Maintaining or increasing range of motion | |
| Technological Comparison: | The CARE ETS™ 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 ETS™ is substantially equivalent to that of the<br>predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARE<br>ETS™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE ETS™ 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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Mr. Christian Hunt President Care Rehab and Orthopedic Products, Inc. P.O. Box 580 McLean, Virginia 22101

Re: K023036

Trade/Device Name: Regulation Number: 21 CFR 890.5850, 21 CFR 882.5050 Regulation Name: Powered muscle stimulator, Biofeedback device Regulatory Class: II Product Code: IPF, HCC Dated: March 21, 2003 Received: March 21, 2003

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), 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) you may obtain. 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 vours.

Mark H. Millken

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 বা

510(k) Number:

Device Name: CARE ETS™

#### Statement of Indication of Use (in EMG Mode):

- Biofcodback 1.
- Relaxation Training 2.
- 3. Muscle Rc-Education

### Statement of Ladication of Use (in NMS Mode):

The Care ETS is recommended for use for the following conditions:

- Relaxation of muscle spasms 】.
- Prevention or retardation of disuse atrophy 2
- ಗ Increasing local blood circulation
- Muscle recordication র্ব
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis . ਨ.
- Maintaining or increasing range of motion. ర్
- 7. Stroke Rehabilitation, using muscle re-education techniques

### PLASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milliken

(Divisio Jigi-Off) Division of General. Restorative and Neurological Devices

510" number K02309

A 20:51 E 0005 81 MUL

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