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510(k) Data Aggregation

    K Number
    K082970
    Device Name
    MARVEL WHEELCHAIR, MODEL EDCAL01
    Manufacturer
    ROGUE WHEELS INC
    Date Cleared
    2008-12-12

    (67 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROGUE WHEELS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Marvél Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
    Device Description
    The Marvél Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position. It can be operated on most indoor and outdoor surfaces, with the exception of stairs. The frame is constructed primarily of aluminium but with titanium elements in specific areas to reduce vibration and weight. Large rear wheels with handrims propel the chair and smaller front pivoting casters provide stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair. The Marvel wheelchair consists of three major components or sections in addition to the large rear whecls: the caster wing assembly, the main frame assembly and the seating assembly. The Marvel Wheelchair offers modularity and a number of adjustability features. The seat height, width, angle, rear seat-to-floor height, and front seat-to-floor height may be adiusted easily for the comfort of the user. Modularity allows replacement of worn components and allows the user to continually customize their own chair to ensure optimal functionality for their lifestyle.
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