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510(k) Data Aggregation

    K Number
    K101087
    Device Name
    REPROCESSED RESTEP COMPRESSION SLEEVES
    Date Cleared
    2010-07-16

    (88 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASCENT HEATLHCARE SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.
    Device Description
    The Restep Deep Vein Thrombosis (DVT) System, consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves. Note: Only the compression sleeves (garments) are the subject of this submission, the pump is not included in the scope of this submission.
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