RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES by RICH-MAR CORP.

This document is a 510(k) clearance letter from the FDA for therapeutic ultrasound devices. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill your request based on the provided text.

Summary

{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
1. Muscle Spasms
1. Joint contractures

But NOT for the treatment of malignancies

Prescription Use
(Per 21 CFR 801.109)

trosello

Regulation Number and Section

N/A