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510(k) Data Aggregation

    K Number
    K120391
    Device Name
    MR4500 WHEELCHAIR
    Date Cleared
    2012-12-21

    (318 days)

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

    WARDRAY PREMISE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.
    Device Description
    The Wardray Premise MR 4500 is a manually operated wheelchair that is propelled by human power. Its intended function and use is to provide mobility to person limited to a sitting position. It may be used as an attendant propelled transport device in a healthcare environment such as a hospital, nursing home or extended care facility. The wheelchair consists primarily of an aluminum frame; 12inch rear wheels and 5-inch front casters and handles for the wheelchair to be pushed. It is folding or non-rigid type of wheelchair that is designed for use by a patient weighing up to 280 lbs. The frame is constructed of one inch (1) outside diameter Aluminum tube that is welded that has a wall thickness of 1/8 inch. The rear urethane wheels are fixed and front are urethane casters.
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