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

    SCOOTA BUG (MOTORIZED VEHICLE)

    K Number: K880424 · Decision Feb 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    14
    Review Days
    15

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    Basic Information

    Device Name
    SCOOTA BUG (MOTORIZED VEHICLE)
    K Number
    K880424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    A-Bec Mobility, Inc.
    Date Received
    February 1, 1988
    Decision Date
    February 16, 1988
    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 A-Bec Mobility, Inc.

    K Number Device Name
    K880425 STERLING (MOTORIZED VEHICLE)
    K880423 TARGA (WHEELCHAIR)
    K865005 A-BEC 41
    K865009 A-BEC 47
    K865004 A-BEC 40 POWER WHEELCHAIR
    K865003 A-BEC 46
    K865008 A-BEC 17
    K865002 A-BEC 18
    K865001 A-BEC FIREBALL 40
    K865006 A-BEC 14
    Search all 14 clearances from A-Bec Mobility, Inc. →