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510(k) Data Aggregation

    K Number
    K180852
    Device Name
    Manual Wheelchair
    Date Cleared
    2019-03-01

    (333 days)

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

    Jiangyin Newrise 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.
    Device Description
    The proposed device, Manual Wheelchair model XSG106A, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport. The main frame is made of magnesium alloy frame, the materials meet the standard of ASTM B107M-2012, and which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base.
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