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

    BOOTS - OUTDOOR CARRIER FOR THE AMIGO

    K Number: K800209 · Decision Feb 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    BOOTS - OUTDOOR CARRIER FOR THE AMIGO
    K Number
    K800209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Amigo Sales, Inc.
    Date Received
    February 1, 1980
    Decision Date
    February 22, 1980
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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    Other Clearances by Amigo Sales, Inc.

    K Number Device Name
    K871391 AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
    K853918 THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
    K852557 ALL TERRAIN AMIGO
    K830345 SCOOTER, VEHICLE MOTORIZED
    K823117 HITCH HIKER
    K820858 ESCORT