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510(k) Data Aggregation

    K Number
    K172103
    Device Name
    Flowtron DVT5 Small Calf Garment
    Date Cleared
    2018-03-02

    (233 days)

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

    Getinge (Suzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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    K Number
    K143438
    Device Name
    Flowtron ACS900
    Date Cleared
    2015-06-23

    (203 days)

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

    Getinge (Suzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To help prevent Deep Vein Thrombosis (DVT)
    Device Description
    The Flowtron ACS900 is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs. It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments. The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly. Each garment is compressed alternately, applying pressure to the patient's limb to help prevent deen vein thrombosis.
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