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

    DONWAY SPLINT

    K Number: K843522 · Decision Feb 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    5
    Review Days
    153

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    Basic Information

    Device Name
    DONWAY SPLINT
    K Number
    K843522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Australian Biomedical Corporation , Ltd.
    Date Received
    September 7, 1984
    Decision Date
    February 7, 1985
    Product Code
    ITH
    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
    ITH Equipment, Traction, Powered

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    Other Clearances by Australian Biomedical Corporation , Ltd.

    K Number Device Name
    K871735 VOROSCOPE(TM)
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    K851660 DONWAY LIFTING FRAME
    K853114 ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR