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

    ALPHA TRI-KART

    K Number: K841919 · Decision May 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    327
    Applicant Total
    10
    Review Days
    13

    Basic Information

    Device Name
    ALPHA TRI-KART
    K Number
    K841919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    ALPHA UNLIMITED, INC.
    Date Received
    May 10, 1984
    Decision Date
    May 23, 1984
    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 ALPHA UNLIMITED, INC.

    K Number Device Name
    K894646 #556 DISPOSABLE UMBILICAL CORD CLAMP (2)
    K893429 ALPHA CONDOR
    K893428 ALPHA SHOPPER
    K893248 ALPHA MALLARD
    K853766 ALPHA SUPER KART
    K841920 MAC-MULTI-ADJUSTABLE CHAIR
    K841911 ALPHA PUSH KART
    K841912 ALPHA 4 X 4
    K841921 ALPHA PLUS 1