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

    THE SPORTSTER (ELECTRIFIED WHEELCHAIR)

    K Number: K853918 · Decision Jan 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    327
    Applicant Total
    7
    Review Days
    112

    Basic Information

    Device Name
    THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
    K Number
    K853918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    AMIGO SALES, INC.
    Date Received
    September 23, 1985
    Decision Date
    January 13, 1986
    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 SALES, INC.

    K Number Device Name
    K871391 AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
    K852557 ALL TERRAIN AMIGO
    K830345 SCOOTER, VEHICLE MOTORIZED
    K823117 HITCH HIKER
    K820858 ESCORT
    K800209 BOOTS - OUTDOOR CARRIER FOR THE AMIGO