ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M

K020130 · Rolor Electronics Corp. · IPF · Dec 2, 2002 · Physical Medicine

Device Facts

• Record ID: K020130
• Device Name: ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
• Applicant: Rolor Electronics Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Specific indications: used to apply an electrical current to electrodes on . patient's skin to function as: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy Increasing local blood circulation. Maintaining or increasing range of motion.

Device Story

The ROLOR Powered Muscle Stimulator GP-8016M is a prescription-use device that delivers electrical current to electrodes placed on a patient's skin. It functions to relax muscle spasms, prevent or retard disuse atrophy, increase local blood circulation, and maintain or increase range of motion. The device is intended for clinical or professional use to assist in physical therapy and rehabilitation. By applying controlled electrical stimulation, the device induces muscle contraction or relaxation, providing therapeutic benefits to patients suffering from muscle-related conditions or disuse.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850, Product Code IPF). Operates by delivering electrical current via skin-surface electrodes. Class II device.

Indications for Use

Indicated for patients requiring electrical muscle stimulation for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

DEC 02 2002

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Dr. Jen. Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, ROC

Re: K020130

Trade/Device Name: ROLOR POWERED MUSLCE STIMULATOR GP-8016M Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II -Product Code: IPF Dated: October 18, 2002 Received: October 25, 2002

Dear Dr. Jen:

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

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product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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,

Miriam C. Provost

Cor 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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## ROLOR ELECTRONICS CORPORA ANIDAD HEALTH INDUSTRIES

No. 274, Nanking E. Road, Sec: 5, Taipei, Taiwan, R.O.C. P.O. Box 46-379 TEL: [phone], FAX: [phone]

Email:

| Applicant: | Rolor Electronics Corp. |
|---------------------------|------------------------------------------|
| 510(k) Number (if known): | k020130 |
| Device Name: | ROLOR POWERED MUSCLE STIMULATOR GP-8016N |

Indications for use:

- Specific indications: used to apply an electrical current to electrodes on . patient's skin to function as:
Relaxation of muscle spasms.

Prevention or retardation of disuse atrophy

Increasing local blood circulation.

Maintaining or increasing range of motion.

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

Concurrence of CDRH, office of Device Evaluation (ODE )

| Prescription Use | <div style="text-align:left;">✓</div> |
|-----------------------|---------------------------------------|
| (Per 21 CFR 801.109 ) | |

OR

| Over – The – Counter – Use | |
|----------------------------|--|
| ( Optional Format 1-2-96 ) | |

*Miriam C. Provost*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices00 No No No2 0130