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    K Number
    K172103
    Device Name
    Flowtron DVT5 Small Calf Garment
    Manufacturer
    Getinge (Suzhou) Co., Ltd.
    Date Cleared
    2018-03-02

    (233 days)

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

    Getinge (Suzhou) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    • To help prevent Deep Vein Thrombosis (DVT)
    Device Description
    The Flowtron Small Calf Garment is a wraparound Calf garment comprising of a bladder and surrounding material intended to apply cyclic compression to calf to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT). The Flowtron Small Calf Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Calf Garment in a cyclic manner. Flowtron Calf Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps
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