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510(k) Data Aggregation

    K Number
    K133119
    Device Name
    FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
    Date Cleared
    2014-02-28

    (151 days)

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

    ARJOHUNTLEIGH POLSKA SP Z.O.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To help prevent Deep Vein Thrombosis (DVT)
    Device Description
    The Flowtron ACS800 pump 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 deep vein thrombosis.
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    K Number
    K122330
    Device Name
    FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
    Date Cleared
    2012-12-07

    (127 days)

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

    ARJOHUNTLEIGH POLSKA SP Z.O.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prevention of Deep Vein Thrombosis (DVT) Enhancement of venous & arterial circulation Prevention of venous stasis Assist healing of cutaneous ulcers Reduction of acute or chronic edema Reduction of lower limb pain due to surgery or trauma Reduction of compartmental pressures
    Device Description
    The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT). The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner. Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps.
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