(474 days)
The W28 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only.
W28 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W28 has a physical dimension of 1100mm × 908mm (depth × width × height) with the seat itself has a dimension of 415mm × 500mm × 475mm (depth × height). The device has a weight capacity of 136 kilograms, and weighs about 20.5 kilograms. The color is dark black.
Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.
The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel, rear wheel, handrim, wheel lock, caster, caster fork, footrest, footplate.
Main materials: Steel (frame, armrest, wheel lock, caster fork, footrest, footplate), PVC (handgrip, side panel, handrim, caster, back upholstery, seat upholstery, armrest pad, rear wheel)
The provided text describes the regulatory clearance for the "Manual Wheelchair (Model W28)" and its substantial equivalence to a predicate device. It does not describe an AI/ML powered medical device, an acceptance criteria table related to AI model performance, or a study to prove an AI model meets acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided document. The document details the physical characteristics, performance standards, and biocompatibility of a manual wheelchair.
However, I can extract the acceptance criteria and study information related to the manual wheelchair's physical and performance aspects if that is what you intended. Please clarify if you are interested in the acceptance criteria and performance study for the manual wheelchair itself, rather than an AI/ML device.
§ 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).