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510(k) Data Aggregation

    K Number
    K111720
    Device Name
    AVIAFIT
    Manufacturer
    Date Cleared
    2011-09-16

    (88 days)

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

    FLOWMEDIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AviaFit 110 Device is intended for use to help prevent the onset of DVT in patients by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to aid in the prevention of DVT, enhance blood circulation, diminish postoperative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
    Device Description
    The FlowMedic AviaFit™ is a battery operated portable device integrating a patented mechanical intermittent compression technology to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions. The device is comprised of an actuator and is externally mounted on the calf. The anatomical concave shaped control unit is connected to the leg strap and applied to the calf. Using an innovative low power consumption mechanism, the system tugs and releases the leg strap placed around the calf muscle, thus exerting intermittent cycles of external pressure build-up on the tissue, and a subsequent release, thus aiding venous return. Strap tug and release are controlled by a system of gears, springs, a motor and integrated microprocessor contained in the plastic control unit. The device mimics the muscle activity during walking by acting sequentially in cycles of an active interval of exerting pressure on the muscle, thus augmenting blood flow. followed by a loose state for a period of time, allowing blood flow to return to the limb.
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    K Number
    K071744
    Device Name
    AVIAFIT PULSATING LEGBAND
    Manufacturer
    Date Cleared
    2007-09-25

    (90 days)

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

    FLOWMEDIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.
    Device Description
    AviaFit™ Pulsating Legband
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