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510(k) Data Aggregation

    K Number
    K113275
    Device Name
    COMPRESSIBLE LIMB THERAPY SYSTEM
    Manufacturer
    WONJINMULSAN CO., LTD.
    Date Cleared
    2012-02-27

    (115 days)

    Product Code
    IRP, CLA
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    WONJINMULSAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.
    Device Description
    Power Q1000 Premium is used with four chamber garments for full leg, and period has its own variable duration pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators. Power Q1000 Premium is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs.
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