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    K Number
    K021102
    Device Name
    DM SLEEVE
    Manufacturer
    EMILY IKER M.D., A.P.C.
    Date Cleared
    2002-05-08

    (34 days)

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

    EMILY IKER M.D., A.P.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of: Lymphedema and other edematous conditions, phlebitis, and vascular malformations.
    Device Description
    The DM Sleeve™ consists of a cotton and nylon fabric, which is fitted to the extremity. The DM Sleeve™ applies non-gradient pressure to move interstitial fluid into venous and lymphatic channels. The DM Sleeve™ applies pressure by means of foam protrusions.
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