CEFAR REHAB 2 AND REHAB 2 PRO

K030403 · Cefar Medical AB · IPF · Jul 17, 2003 · Physical Medicine

Device Facts

• Record ID: K030403
• Device Name: CEFAR REHAB 2 AND REHAB 2 PRO
• Applicant: Cefar Medical AB
• Product Code: IPF · Physical Medicine
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

Device Story

Battery-powered handheld NMES device; delivers symmetrical biphasic electrical pulses via skin electrodes to stimulate muscles. Features two channels; 22 preset stimulation programs; PRO model allows user-defined parameter settings. Amplitude adjustable 0-100 mA; pulse rate 2-120 Hz. Operated by clinician or patient under medical supervision in clinical or home settings. LCD displays program info and amplitude. Output controlled via pushbuttons. Used for muscle re-education, spasm relaxation, circulation improvement, and atrophy prevention. Benefits include non-invasive therapeutic muscle stimulation to support rehabilitation and post-surgical recovery.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC EN 60601-1 (general safety) and IEC EN 60601-1-2 (EMC) verified by external testing (SEMKO AB).

Technological Characteristics

Battery-powered (2xAA) NMES device; two-channel output; symmetrical biphasic rectangle waveform; 0-100 mA amplitude; 50-300 µs pulse width; 2-120 Hz pulse rate. LCD interface with pushbutton controls. Complies with IEC EN 60601-1 and IEC EN 60601-1-2.

Indications for Use

Indicated for patients requiring adjunctive therapy for 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. Use is restricted to medical supervision.

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 Rehabilicare (K971542)

Submission Summary (Full Text)

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K030403

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# APPENDIX I. 510(K) SUMMARY

## Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the CEFAR Medical AB summary for the CEFAR REHAB 2 and REHAB 2 PRO:

| SUBMITTER'S NAME: | CEFAR Medical AB |
|---------------------|----------------------------------------------|
| ADDRESS: | Scheelevagen 19A<br>SE-223 70 Lund<br>Sweden |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | February 4, 2003 |

#### 1. Identification of device

Proprietary Name: CEFAR REHAB 2 and REHAB 2 PRO Common Name: Powered muscle stimulator Classification Status: Class II per regulations 890.5850 Product Codes: IPF

### 2. Equivalent devices

CEFAR Medical AB believes the CEFAR REHAB 2 and REHAB 2 PRO is substantially equivalent to:

Powered Muscle Stimulator Ortho DX Rehabilicare K971542

### 3. Description of the Device

The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.

Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.

### 4. Intended use

The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include:

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

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### 5. Comparison to predicate device.

### Comparison table

| Characteristic | Ortho DX<br>(Predicate device) | CEFAR REHAB 2 and<br>CEFAR REHAB 2 PRO |
|------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for use statement | Identical | See Section 1 B Indications for<br>Use Statement |
| Prescription device | Yes | Yes |
| Number of channels | 2 | 2 |
| Output | 0-100 mA | 0-100 mA |
| Wave form | Symmetrical biphasic rectangle<br>with zero net DC | Symmetrical biphasic<br>rectangle with zero net DC |
| Pulse width | 0-300 $ \mu $ s | 50-300 $ \mu $ s |
| Maximum charge per<br>pulse | 30 $ \mu $ C | 30 $ \mu $ C |
| Pulse rate | 33.3 Hz, fixed | 2-120 Hz, fixed in each<br>preset program |
| Transcutaneous current<br>delivery | Yes, through electrodes placed<br>on patients body | Yes, through electrodes<br>placed on patients body |
| User control of output | Yes, knobs | Yes, pushbuttons |
| Power supply | Yes, battery operated 4xAA<br>batteries (rechargeable or<br>alkaline) | Yes, battery operated 2xAA<br>batteries (rechargeable or<br>alkaline) |

### Discussion of functional and safety testing. 6.

An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment.

Notified body SEMKO AB, with ID 0413, has performed the external testing.

#### 7. Conclusion

Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of CEFAR Medical AB that the CEFAR REHAB 2 and CEFAR REHAB 2 PRO are substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name around the perimeter. Inside the circle is a stylized image of three abstract shapes, possibly representing human figures or elements of health and well-being.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2003

CEFAR Medical AB c/o Ms. Constance G. Bundy C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432

Re: K030403

Trade/Device Name: CEFAR REHAB 2 and CEFAR REHAB 2 PRO Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Codes: IPF Dated: May 7, 2003 Received: May 12, 2003

Dear Ms. Bundy:

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 - Ms. Constance G. Bundy

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,

Mark A. Millerson

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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# 1.B. Indications for Use KO30403 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: CEFAR REHAB 2 and CEFAR REHAB 2 PRO

## Indications for Use:

The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include:

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

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use

for Mark N Mulkern
(Division Si

ision of Genera . Restorative dological f

510(k) Number K030403

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