(168 days)
It 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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Mobility Scooter. It is a regulatory document and does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the given input. This document is a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a study report detailing performance metrics.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).