MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 8 2002 Mr. David Richards Vice President. Director of Regulatory Affairs Rich-Mar Corporation P.O. Box 879 Inola, Oklahoma 74036-0879 Re: K013771/S1 Trade/Device Name: Winner CM-2 Regulation Numbers: 21 CFR 890.5850, 890.5300(a), 890.5860(a), and 882.5890 Regulation Names: Powered Muscle Stimulator, Ultrasonic Diathermy, Ultrasound and Muscle Stimulator, and Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Codes: IPF, IMI, IMG, GZJ and LIH Dated: December 13, 2001 Received: January 7, 2002 Dear Mr. Richards: 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 {1}------------------------------------------------ Page 2 - Mr. David Richards 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. 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 legally marketed predicate devices 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, L. Mark N. Melkman 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 {2}------------------------------------------------ l of l Page 510(k) Number (if known): K013771 Device Name: Rich-Mar Winner CM2 Indications For Use: Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms: - 1. Relaxation of muscle spasms. - 2. Prevention or retardation of disuse atrophy. - 3. Increasing local blood circulation. - 4. Muscle re-education. - 5. Maintaining or increasing range of motion. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6. Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms: - 1. Symptomatic relief of chronic intractable pain. - 2. Management of pain associated with post-traumatic or post operative conditions. Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: - l. Relief of pain - 2. Muscle spasms - 3. Joint contractures But NOT for the treatment of malignancies (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) *Mark n Mill* (Division Sign-Off) Γ.ision of General, Restorative Neurological Devices Number K013771 \\SERVER1\Public\FDA\winner cm2 special 510k\INDICATIONS FOR USE FORM-combo.doc