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510(k) Data Aggregation

    K Number
    K022340
    Device Name
    TRAVELAIR PORTABLE COMPRESSION SYSTEM
    Manufacturer
    DYNAMIC AIR, INC.
    Date Cleared
    2003-02-19

    (216 days)

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

    DYNAMIC AIR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TravelAir Portable Compression System is intended to assist in the relief of the following: Fatigue in the lower limbs Venous congestion in the lower legs Edema in the lower legs Edema in the lower legs post injury or trauma Prevention of Deep Vein Thrombosis
    Device Description
    The Dynamic Air, Inc. TravelAir Portable Compression System consists of a battery operated compression pump connected to an inflatable leg wrap. The compression pump is connected to the leg wrap by plastic tubing connected by CPC quick connectors at the pump and at the tubing /wrap junction. The leg wrap consists of a Polyvinyl chloride (PVC) air bladder encapsulated inside a VelFoam material; the color of the outer covering material is white. The VelFoam material is adhered to the PVC air bladder. The wrap is provided clean, non-sterile packaged in pairs for use. The compression pump consists of a medical grade micro pump which delivers preset pressures to the leg wraps. The micro pump is controlled by a microchip controller board which regulates pressure and compression time on a set cycle. The compression pump inflates and deflates the leg wraps in a preset sequence intermittently compressing the soft tissue of the legs. This compression forces blood to move toward the heart and enhances venous return from the lower legs. After compression the wraps deflate and allow the veins and capillaries to refill. The cycle then repeats until the unit is deactivated.
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