BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Wheelchair

    K Number: K163352 · Decision Jul 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    9
    Review Days
    240

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    Basic Information

    Device Name
    Wheelchair
    K Number
    K163352
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Date Received
    November 30, 2016
    Decision Date
    July 28, 2017
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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