BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)

    K Number: K222703 · Decision May 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    2
    Review Days
    254

    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
    ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
    K Number
    K222703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moving Life, Ltd.
    Date Received
    September 7, 2022
    Decision Date
    May 19, 2023
    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

    Other Clearances by Moving Life, Ltd.

    K Number Device Name
    K160909 ATTO Mobility Scooter