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510(k) Data Aggregation

    K Number
    K190534
    Device Name
    Manual Wheelchair SIVFH2A102
    Date Cleared
    2019-05-29

    (86 days)

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

    **Jiangsu Horizon Medical Science **& Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Manual Wheelchair is to provide mobility to persons restricted to a sitting position.
    Device Description
    The Aluminum Manual Wheelchair is indoor/outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat. Main components: Main frame, handle sleeve, back upholstery, seat upholstery, armrest, side panel, rear wheel with handle ring, rear wheel axle, legrest, footplate, front fork, front wheels, cross bar. Main materials: Main frame, cross bar, legrest: Aluminum, silver/blue coating Back upholstery, seat upholstery: Cover is polyester non-woven, inside with flame resistant foam Handle sleeve, handle sleeve, side panel, handle ring, footplate: PVC Tire of rear wheels, front wheels, armrest pad: PU
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