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510(k) Data Aggregation
K Number
K170517Device 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
890.3850Why 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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