(268 days)
The Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.
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.
This document is a 510(k) premarket notification for a mechanical wheelchair, NOT an AI/ML medical device. Therefore, the requested information about acceptance criteria for an AI/ML device and the study proving it meets them cannot be extracted from this text. The document details the substantial equivalence of the Merits Model R106/R136 Rehab Wheelchair to a predicate device based on non-clinical testing and comparison of physical characteristics, not AI performance.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).