BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Wheelchair, Stair Climbing

    PMA: P020033 · Supplement: S002 · Decision Mar 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Wheelchair, Stair Climbing
    Trade Name
    INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM
    PMA Number
    P020033
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    IMK
    Generic Name
    Wheelchair, stair climbing
    Regulation Number
    890.3890
    Medical Specialty
    Physical Medicine
    Advisory Committee
    Physical Medicine
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 15, 2005
    Date Received
    September 9, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR GENERATIONAL CHANGES TO THE APPROVED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDEPENDENCE IBOT 4000 MOBILITY SYSTEM. THE DEVICE IS INDICATED FOR INDIVIDUALS WHO HAVE MOBILITY IMPAIRMENTS AND THE USE OF AT LEAST ON UPPER EXTREMITY. THE DEVICE IS INTENDED TO PROVIDE MOBILITY ON SMOOTH SURFACES AND INCLINES AT HOME, AT WORK ,AND IN OTHER ENVIRONMENTS; MOVEMENT ACROSS OBSTACLES, UNEVEN TERRAIN, CURBS, GRASS, GRAVEL AND OTHER SOFT SURFACES; MOBILITY IN A SEATED POSITION AT AN ELEVATED HEIGHT; ASCENT AND DECENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IMK Wheelchair, Stair Climbing