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510(k) Data Aggregation

    K Number
    K042699
    Device Name
    ABILITY POWER GURNEY
    Date Cleared
    2005-03-16

    (167 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    GATOR CUSTOM MOBILITY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair.
    Device Description
    The Ability Power Gurney is a battery powered, motor driven device consisting of a platform mounted on a wheeled frame that is designed to provide mobility and transportation to physically challenged persons that may be restricted to a horizontal position. The device may have patient securement straps and supports for fluid infusion equipment. A Penny and Giles VSI controller joystick and a 70amp controller is used to operate the Ability Power Gurney, the same as the predicate device, the Invacare Storm Power Wheelchair. The Ability Power Gurney is powered by two 12VDC, Group U-1 Gel Batteries and has a range of up to 15 miles on a full charge. The base of the stretcher is made of welded steel construction. The Ability Power Gurney and the predicate both have a caster mounted design with a variable height top surface. The top may be controlled by the client for pressure relief and access to different heights. Optional material meets California 117 standards for fire retardancy.
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