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

    SupaScoota Motorized vehicle

    K Number: K143557 · Decision Sep 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    4
    Review Days
    275

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    Basic Information

    Device Name
    SupaScoota Motorized vehicle
    K Number
    K143557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurogreen International, Inc.
    Date Received
    December 15, 2014
    Decision Date
    September 16, 2015
    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 Eurogreen International, Inc.

    K Number Device Name
    K182631 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
    K173313 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
    K173315 SupaChair Powered Wheelchair