(49 days)
The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, studies, ground truth, or sample sizes related to the Electric Wheelchair (YHW001-C; YHW001-D; YHW001-E; YHW001-F).
The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as product classification, general controls, quality system regulations, adverse event reporting, and other compliance requirements.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).