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

    Electric Scooter (Mojo-T580)

    K Number: K252347 · Decision Jan 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    2
    Review Days
    184

    Basic Information

    Device Name
    Electric Scooter (Mojo-T580)
    K Number
    K252347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan Smarfody Mobility Technology Co., Ltd.
    Date Received
    July 29, 2025
    Decision Date
    January 29, 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

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    Other Clearances by Dongguan Smarfody Mobility Technology Co., Ltd.

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