RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of a bird, possibly an eagle, with its wings spread. NOV 1 9 1000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. David Richards Director of Quality and Regulatory Affairs Rich-Mar Corporation P.O. Box 879 74036-0879 Inola, Oklahoma K982544 Re : Rich-Mar US500, US750, US1000, Therapeutic Ultrasound Devices Requlatory Class: II Product Code: IMI Dated: October 6, 1998 Received: October 16, 1998 Dear Mr. Richards: We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {1}------------------------------------------------ Page 2 - Mr. David Richards This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally Finaling of basean devices results in a classification for marketed predicate actions permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation encreted, "hibranding by other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from ene (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## INDICATIONS FOR TREATMENT ## THERAPEUTIC ULTRASOUND: 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 **Prescription Use** (Per 21 CFR 801.109) trosello