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

    GOLDEN HAWK

    K Number: K971050 · Decision Aug 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    8
    Review Days
    133

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    Basic Information

    Device Name
    GOLDEN HAWK
    K Number
    K971050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Golden Technologies, Inc.
    Date Received
    March 21, 1997
    Decision Date
    August 1, 1997
    Product Code
    INI
    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
    INI Vehicle, Motorized 3-Wheeled

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    Other Clearances by Golden Technologies, Inc.

    K Number Device Name
    K063162 GOLDEN LITEWAY
    K041341 GOLDEN SPYDER, MODEL GS-300
    K041025 BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
    K012258 COMPANION MODEL 221, 321, 421
    K011153 ALANTE, BATTERY OPERATED POWER WHEELCHAIR
    K971043 GOLDEN EAGLE
    K880800 GOLDEN POWER LIFT CHAIR