BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR

    K Number: K120526 · Decision Mar 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    14
    Review Days
    15

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    Basic Information

    Device Name
    YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
    K Number
    K120526
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Received
    February 22, 2012
    Decision Date
    March 8, 2012
    Product Code
    IOR
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    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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