WALKCARE P200 SYSTEM

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right. The profiles are connected by flowing lines that resemble a ribbon or stream. MAY 20 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Ahava Stein Requlatory Affairs Consultant, for Medical Dynamics Ltd, P.O. Box 454 Ginot Shomron, 44853 ISRAEL K973592 Re : WalkCare P200 System Regulatory Class: II (Two) 74 Jow Product Code: Dated: December 31, 1998 Received: March 16, 1999 Dear Mr. Stein: 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 leqally 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). 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 aqainst 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 requlations affecting your device 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 GMP 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 requlations. {1}------------------------------------------------ Page 2 - Mr. Ahava Stein This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding acberibed in four and 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro reguration (ar oris), please contact the Office of Compliance at Glaghostic devices), prease venture on the promotion and advertising of your device, please contact the Office of advertibing of your acticles, . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. Calladan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement Page 1 of 1 | 510(k) Number (if known): | K973592 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | WalkCare P200 - A foot compression system | | Indications for use: | The Walkcare P200 system is indicated for improved blood circulation, prevention of deep vein thrombosis and reduces pain, chronic and acute edema, leg ulcers, compartmental pressure, venous stasis and complications of poor circulation, in the lower extremeties. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) le Of Impeче (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K97359z 510(k) Number _ OR ______________________________________________________________________________________________________________________________________________________________________________ Prescription Use _ سا (Per 21 C.F.R. 801.109) · . . ______________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (Optional Format 1-2-96) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------