BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    Kudu

    K Number: K151492 · Decision May 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    5
    Review Days
    352

    Basic Information

    Device Name
    Kudu
    K Number
    K151492
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R82 A/S
    Date Received
    June 3, 2015
    Decision Date
    May 20, 2016
    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

    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 R82 A/S

    K Number Device Name
    K100084 MULTI FRAME WHEELCHAIR
    K061810 COUGAR WHEELCHAIR
    K033460 CHEETAH WHEELCHAIR
    K030882 RABBIT MOBILE STANDING FRAME