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

    Mobility Scooter (Model X-01, X-02)

    K Number: K242975 · Decision May 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    1
    Review Days
    223

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    Basic Information

    Device Name
    Mobility Scooter (Model X-01, X-02)
    K Number
    K242975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuyi Aichi Industry & Trade Co., Ltd.
    Date Received
    September 26, 2024
    Decision Date
    May 7, 2025
    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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