MSI MAGNA-STYM

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the eagle in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Larry Cohen, D.P.M. Microvas Systems, Inc. 400 North Loop 1604, Suite 340 San Antonio, Texas 78232 AUG 29 9 ... ........ Re: K972055 Trade Name: MSI Magna-Stym Regulatory Class: II Product Code: IPF May 19, 1997 Dated: June 2, 1997 Received: Dear Dr. Cohen: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device 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 regulations. {1}------------------------------------------------ Page 2 - Dr. Cohen This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Miberes 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}------------------------------------------------ j01(k) Number (if known): K972055 Device Name: MSI Magna-Stym Indications For Use: The proposed device will have the following indications: prevention and retardation of muscle disuse atrophy, increase local blood flow, increase range of motion, prevent venous thrombosis with immediate postsurgical stimulation of calf muscles; relaxation of muscle spasms. Mali M Millman Image /page/2/Picture/6 description: The image contains a chemical structure diagram on the left and some text on the right. The chemical structure appears to be a simple organic molecule, possibly an ether. The text on the right includes the word 'Division' and the number '51'. (Division Sign-Off) Division of General Restorative Devices 510(k) Number K972055 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ﺎ Prescription Use (Per 21 CFR 801.109) Or Over The Counter Use (Optional Format 1-2-96)