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

    AMIGO CLASSIC FD

    K Number: K101507 · Decision Jul 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    8
    Review Days
    59

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    Basic Information

    Device Name
    AMIGO CLASSIC FD
    K Number
    K101507
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amigo Mobility Intl., Inc.
    Date Received
    June 1, 2010
    Decision Date
    July 30, 2010
    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 Amigo Mobility Intl., Inc.

    K Number Device Name
    K092936 AMIGO ESCORT 7.5, MODEL 760001 PHS
    K010503 AMIGO WHEELCHAIR
    K992619 AMIGO MODEL 680000 (AMIGO EXCITE F 350)
    K983987 AMIGO MODEL 590000
    K981121 AMIGO RT
    K952112 AMIGO GRAND TOUR
    K940334 AMIGO J-9