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

    VARIOUS MODELS OF WHEELCHAIRS

    K Number: K904522 · Decision Nov 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    VARIOUS MODELS OF WHEELCHAIRS
    K Number
    K904522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Hadco Marketing Services, Inc.
    Date Received
    October 2, 1990
    Decision Date
    November 26, 1990
    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 Hadco Marketing Services, Inc.

    K Number Device Name
    K904650 WHEELCHAIR CONVERSION KIT