HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human figures. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DM Systems, Incorporated C/O Mr. Michael Zmuda Z-Technologie, S.P. 1105 Buchbrush Drive Folsm, California 95630 JAN 1 3 2011 Re: K101614 Trade/Device Name: HeelSafe" DVT Hose Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: December 30, 2010 Received: January 3, 2011 Dear Mr. Zmuda: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ Page 2- Mr. Zmuda Enclosure 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Jams I Ressaud for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ## EXHIBIT E ## INDICATIONS FOR USE STATEMENT (Amendment) ## 510(k) Number: K101614 Device Common Name: Medical Support Stocking Device Proprietary Name: HeelSafe™ DVT Hose Indications for Use: To prevent the pooling of blood and deep vein thrombosis in the legs. Intended Uses: For patients at risk of developing compromised or inadequate venous return from the legs as a result of both medical and non-medical circumstances. > The HeelSafe DVT Hose are designed to aid and prevent deep vein thrombosis in the recumbent patient with limited mobility. Progressive compression from foot to knee aids in improving venous return and avoiding clot formation. The HeelSafe DVT Hose open heel aids in preventing pressure on the heel that could be caused by the additional 15-18 mm Hg of pressure of other compression stockings. The HeelSafe DVT Hose open heel allows for easy visualization and palpation of the heel at all times. Prescription Use? NO (21 CFR 801 Subpart D) Over-the-Counter Use? YES (21 CFR 801 Subpart C) Rell C. 1/12/11 Olvision Sign-Off) Division of Anesthesiology, General Hospital Titlection Control, Dental Devices 510(k) Number: K/0/6/4 000101 C 2010 DM Systems, Inc. HeelSafeTM 510(k) Amendment (K101614) CONFIDENTIAL Page 1/1 v. 10/8/10