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510(k) Data Aggregation

    K Number
    K051369
    Device Name
    SYRYKER SORANO WHEELCHAIR
    Manufacturer
    STRYKER CANADA
    Date Cleared
    2005-09-26

    (123 days)

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

    STRYKER CANADA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
    Device Description
    The Stryker Sorano Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position. The product consists of a titanium frame (also available in chrome-moly steel), large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for 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 Stryker Sorano offers a suspension system made of a fibre glass composite. The two suspension elements are part of the frame construction as they connect the main frame to the rear wheel axle. As it is part of the frame, the suspension is a standard feature. The Stryker Sorano offers an additional propulsion method to conventional handrims. A lever drive option may be added that provides two forward gear ratios an incorporates a disc braking system. Handrim use is still possible as handrims are standard on all units. The key benefits to the drive system are that it eliminates the need to grip the handrim, provides mechanical advantage and provides an enhanced braking system. The Stryker Sorano also offers modularity and adjustability features. The seat height, angle, rear seat-to-floor height, and front seat-to-floor height may be adjusted by the end user. The footrest module with caster wheels may be adjusted forward and backward, and the footrest height may be adjusted. The backrest angle and height may also be adjusted. In addition, the footrest module is removable and may be replaced with optional sports or other special purpose footrests. The seat/backrest module and the footrest module may be removed by the user, allowing the entire wheelchair to be packed in a compact space for travel. The optional folding backrest enhances this feature.
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