BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    UROK ROCKING WHEELCHAIR, MODEL 700-4XX

    K Number: K052548 · Decision Jan 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    2
    Review Days
    112

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    UROK ROCKING WHEELCHAIR, MODEL 700-4XX
    K Number
    K052548
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amg Medical, Inc.
    Date Received
    September 16, 2005
    Decision Date
    January 6, 2006
    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.

    ICON 35; ICON 45; ICON 60; ICON 30FAF

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (LW01108)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Helio Kids; Apex P

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (DY01903(2))

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (7101L, 7102LHD)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))

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

    Other Clearances by Amg Medical, Inc.

    K Number Device Name
    K940380 AMG MED BRAND CLINICAL GLASS THERMOMETER