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

    Scooter (Model: FDB01)

    K Number: K201196 · Decision Jun 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    2
    Review Days
    417

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    Basic Information

    Device Name
    Scooter (Model: FDB01)
    K Number
    K201196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
    Date Received
    May 4, 2020
    Decision Date
    June 25, 2021
    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 Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

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