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510(k) Data Aggregation

    K Number
    K101614
    Device Name
    HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
    Manufacturer
    DM SYSTEMS, INCORPORATED
    Date Cleared
    2011-01-13

    (218 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    DM SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To prevent the pooling of blood and deep vein thrombosis in the legs. 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.
    Device Description
    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.
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