BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FORMULA IV ELECTRIC MOBILITY VEHICLE

    K Number: K954378 · Decision Jul 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    1
    Review Days
    310

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    Basic Information

    Device Name
    FORMULA IV ELECTRIC MOBILITY VEHICLE
    K Number
    K954378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerotek
    Date Received
    September 19, 1995
    Decision Date
    July 25, 1996
    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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