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510(k) Data Aggregation

    K Number
    K220671
    Device Name
    Manual Wheelchair
    Date Cleared
    2022-07-21

    (136 days)

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

    Hebei Ruilangde Medical Equipment Technology Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The Manual Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the wheelchair by rotating two handrims protruding from rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device can be folded for transport. The device can be operated indoor or outdoor on dry, smooth surfaces composed of concrete, blacktop or asphalt under normal driving conditions. The subject manual wheelchair is a mechanical wheelchair with four wheels, including two front casters and two rear wheels, a frame made of carbon steel, a seat and a backrest made of oxford fabric, which is soft and water-resistant, two handles, armrests, handrims, foot pedals, legrest strap and seat belt. The subject manual wheelchair has a physical dimension of 1085mm × 700mm ×935mm (length × width × height). The device has a weight capacity of 100 kilograms, and its total mass is 17.3kg. The color is black.
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