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510(k) Data Aggregation

    K Number
    K112769
    Device Name
    CURAD COMPRESSION HOSIERY
    Manufacturer
    MEDLINE, INDUSTRIES, INC.
    Date Cleared
    2012-03-01

    (160 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CURAD COMPRESSION HOSIERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility.

    15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time.

    20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

    30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the Curad® Compression Hosiery. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device based on its indications for use.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not a performance study with detailed acceptance criteria and results.

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