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510(k) Data Aggregation

    K Number
    K170517
    Device Name
    Merits Model R106/R136 Rehab Wheelchair
    Manufacturer
    Merits Healthcare Industries (suzhou) Co., LTD.
    Date Cleared
    2017-11-16

    (268 days)

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

    Merits Healthcare Industries (suzhou) Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    The Merits Model R106/R136 Rehab Wheelchair are manual wheelchairs. They have adjustable headrest, adjustable armrests, cozy ergonomics seat and multiple axle position. The seat and back are supported by two cylinders, so the fully back reclines can be adjusted from 9° to 57° and seat tilting angles from 4° to 34°. The casters are 7"*1" PU wheels with height adjustable forks and the rear wheels are 24"*1-3/8" polyurethane spoke wheels (R106) or 12-1/2"*2-1/4" polyurethane spoke wheels (R136). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user and the Recline Backrest of the wheelchair, 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". Its seat width is also adjustable: 16" /17" /18" /19" and 20" and seat depth: 18" /19" and 20". 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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