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

    Mobility Scooter (S3)

    K Number: K253643 · Decision Feb 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    2
    Review Days
    91

    Basic Information

    Device Name
    Mobility Scooter (S3)
    K Number
    K253643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Zhimahuaerkai Technology Co., Ltd.
    Date Received
    November 19, 2025
    Decision Date
    February 18, 2026
    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 Shenzhen Zhimahuaerkai Technology Co., Ltd.

    K Number Device Name
    K253707 Electric wheelchair (W1,W3)