BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Scooter

    K Number: K182471 · Decision Jul 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    1
    Review Days
    303

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Scooter
    K Number
    K182471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin Kepler Vehicle Industry Co. , Ltd.
    Date Received
    September 10, 2018
    Decision Date
    July 10, 2019
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.

    Virgo Mobility Scooter (Virgo-D,Virgo-F)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Scooter (YD-03)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (Air Carbon)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (X-12, X-14, X-17)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Electrical Scooter (SM4226)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Power Mobility Scooter (MJMA01, MJMA02)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all