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510(k) Data Aggregation

    K Number
    K981643
    Device Name
    RTM DVT PROSOFT CUFF MODEL NUMBER PS100
    Manufacturer
    R.T. MEDICAL SERVICES, INC.
    Date Cleared
    1998-12-14

    (220 days)

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

    R.T. MEDICAL SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use with the Huntleigh DVT Flowtron pump to aid in the prevention of deep vein thrombosis in surgical, trauma and certain medical patients at risk for DVT formation. It is not intended for use on patients with known DVT or with any other intermittent compression device. This device is restricted to sale by or on the order of a physician.
    Device Description
    The RTM DVT PS100 ProSoft Cuff is a cotton garment designed to be wrapped around the lower extremity (calf), secured with looped tape and connected to Huntleigh DVT Flowtron pump. The outer shell of the garment is a blend of cotton and linen and encases a plastic inflatable bladder that is connected to the pump via poly vinyl tubing.
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