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510(k) Data Aggregation

    K Number
    K180309
    Device Name
    Manual Wheelchair W54
    Date Cleared
    2019-05-03

    (455 days)

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

    Jiangsu Jumao Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.
    Device Description
    A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black. The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork. Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)
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