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

    BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280

    K Number: K033220 · Decision Dec 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
    K Number
    K033220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tung Keng Enterprise Co., Ltd.
    Date Received
    October 3, 2003
    Decision Date
    December 18, 2003
    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 Tung Keng Enterprise Co., Ltd.

    K Number Device Name
    K220156 Electrically Powered Wheelchair, Joy Rider
    K033240 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
    K033239 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
    K033219 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
    K033241 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320