BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRO COMFORT TENNIS ELBOW SUPPORT/WRIST

    K Number: K811035 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    503
    Registration Numbers
    503
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    13

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    Basic Information

    Device Name
    PRO COMFORT TENNIS ELBOW SUPPORT/WRIST
    K Number
    K811035
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Scholl, Inc.
    Date Received
    April 16, 1981
    Decision Date
    April 29, 1981
    Product Code
    IQI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQI Orthosis, Limb Brace

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