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510(k) Data Aggregation

    K Number
    K231750
    Device Name
    MA012 Aluminum wheelchair, MS019 steel wheelchair
    Manufacturer
    Sichuan AST Medical Equipment Co., Ltd.
    Date Cleared
    2023-08-15

    (61 days)

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

    Sichuan AST Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position.
    Device Description
    MA012 Aluminum wheelchair and MS019 Steel wheelchair are mechanical wheelchairs which is a manually operated, attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. The wheelchair is controlled, steered and operated completely by a trained caregiver. The wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. There are two models of the wheelchair, MA012 and MS019. The MA012 Aluminum wheelchair has an aluminum frame, fixed armrest and a foldable back, while the MS019 Steel wheelchair has a steel frame, fixed back and a detachable, flip-back armrest. The wheelchair can support users of up to115 kg.
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    K Number
    K181795
    Device Name
    AST Model MA012 and MS019 Rehab Wheelchair
    Manufacturer
    Sichuan AST Medical Equipment Co., Ltd.
    Date Cleared
    2018-09-25

    (82 days)

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

    Sichuan AST Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.
    Device Description
    The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable. The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel; The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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