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
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    2
    Review Days
    15

    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.

    Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Bowhead ERA Wheelchairs

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (MASY23)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (SYIV100-CA9221)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Merlexi Craft Bariatric series of manual wheelchairs

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

    K Number Device Name
    K083559 YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B