BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IRON HORSE ONE

    K Number: K874246 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    1
    Review Days
    38

    Basic Information

    Device Name
    IRON HORSE ONE
    K Number
    K874246
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    IRON HORSE PRODUCTIONS, INC.
    Date Received
    October 16, 1987
    Decision Date
    November 23, 1987
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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