WINNER CM4 COMBINATION UNIT

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text surrounding a stylized image of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters. The eagle is depicted with three lines forming its wings and body, giving it a modern and abstract appearance. OCT 2 5 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. David Richards Vice President, Director of Regulatory Affairs Rich-Mar Corporation P.O. Box 879 Inola, Oklahoma 74036 Re: K012848 Trade/Device Name: Rich-Mar Winner CM4 Regulation Number: 890.5850, 882.5890, 890.5300, 890.5860 Regulation Name: Powered muscle stimulator Transcutaneous electrical nerve stimulator Ultrasonic diathermy Ultrasound and muscle stimulator Interferential current therapy Regulatory Class: Class II Product Code: IPF, GEJ, IMI, IMG, LIH Dated: July 31, 2001 Received: August 23, 2001 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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ ### Page 2 - Mr. David Richards 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 (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, for Mailh n Melkerson 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}------------------------------------------------ Page 1 of 3 510(k) Number (if known): Device Name: RICH-MAR WINNER CM4 Indications For Use: ### THERAPEUTIC ULTRASOUND Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: KO12848 - 1) 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) for Mark N. Millican (Optional Format 3-10-98) eneral, Restorative ological Devices 510(k) Number K012848 {3}------------------------------------------------ Page 2 of 3 510(k) Number (if known): RICH-MAR WINNER CM4 Device Name:_ KO12848 Indications For Use: ## MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent) Microcurrent output is indicated for the following conditions: I) Symptomatic relief of chronic, intractable pain. 2) Management of pain associated with post-traumatic or post-operative conditions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) for Mark N. Milliken . Restorative ogical Devices K 012848 510(k) Number. (Optional Format 3-10-98) {4}------------------------------------------------ Page 3 of 3 # 12848 510(k) Number (if known): ### RICH-MAR WINNER CM4 Device Name:___ Indications For Use: # Quadpolar, Bipolar, Monophasic and Russian Waveforms This device is indicated for the following conditions: I) 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. 5) Maniaming of mirgical stimulation of calf muscles to prevent venous thrombosis. Powered muscle stimulators should only be used under medical supervision for I divertive therapy for the treatment of medical diseases and conditions. ## (Quadpolar Interferential and Microamperage Pulsed Current) I) Symptomatic relief of chronic, intractable pain, 2) Management of pain associated with post-traumatic or post-operative conditions. (PLE/ NEEDEU) Concurrence of CDRH, Office of Device Evaluation (ODE) Mach N. Milhuner **(Division Sign-Off)** Division of General, Restorative and Neurological Devices 510(k) Number (Optional Format 3-10-98)