(244 days)
Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.
This document is a 510(k) premarket notification for a change in the controller of an existing powered wheelchair. It does not describe a study involving "acceptance criteria" and "device performance" in the context of typical AI/ML medical device evaluations.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device due to a controller change, not on evaluating the performance of a new AI/ML algorithm against predefined metrics.
§ 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).