BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENCIRCLE COMPRESSION THERAPY STOCKING

    K Number: K122485 · Decision Apr 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    252

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    Basic Information

    Device Name
    ENCIRCLE COMPRESSION THERAPY STOCKING
    K Number
    K122485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encircle Medical Devices , Ltd.
    Date Received
    August 14, 2012
    Decision Date
    April 23, 2013
    Product Code
    DWL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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