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510(k) Data Aggregation

    K Number
    K981296
    Device Name
    GEEN MEDISOX
    Date Cleared
    1998-05-29

    (50 days)

    Product Code
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEEN HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GEEN MEDI SOX GRADUATED COMPRESSI ON SOCKS HAVE BEEN DESIGNED TO PREVENT POOLING OF BLOOD I N THE LOWER EXTREMI TI ES BY APPLYI NG CONTROLLED GRADUATED COMPRESSION STARTING AT 20 MMHG AT THE ANKLE AND REDUCING TO 8 MMHG AT THE KNEE. GEEN MEDISOX HELP IN THE TREATMENT AND PREVENTI ON OF VARI COSE VEINS, REDUCE THE FEELING OF HEAVINESS AND TIREDNESS IN LEGS, ESPECIALLY FOR THOSE STANDING OR WALKING ALL DAY, AND ALSO HELP TO REDUCE SWELLI NG IN THE LOWER EXTREMITIES.
    Device Description
    Geen Medisox, a medical support stocking (21 CFR, 880.5780). Geen Medisox help prevent pooling of blood in the lower extremities by providing controlled graduated compression starting at 20 mmhg at the ankle and reducing to 8 mmhg at the knee. Geen Medisox are knit stockings made from cotton, Lycra, and polyamide, with gradual compression provided by the Lycra.
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