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510(k) Data Aggregation

    K Number
    K120166
    Device Name
    COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
    Manufacturer
    WON INDUSTRIAL CO.
    Date Cleared
    2012-05-14

    (116 days)

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

    WON INDUSTRIAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WIC -2008S is intended 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 injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
    Device Description
    WIC-2008S 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.
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    K Number
    K102319
    Device Name
    COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
    Manufacturer
    WON INDUSTRIAL CO.
    Date Cleared
    2011-01-28

    (164 days)

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

    WON INDUSTRIAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WIC-2008 is intended 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 injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
    Device Description
    WIC-2008 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.
    Ask a Question

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