BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    KYMCO FORU, MODEL EQ40

    K Number: K081133 · Decision Jun 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    327
    Applicant Total
    7
    Review Days
    50

    Basic Information

    Device Name
    KYMCO FORU, MODEL EQ40
    K Number
    K081133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KWANG YANG MOTOR CO., LTD.
    Date Received
    April 21, 2008
    Decision Date
    June 10, 2008
    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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