(80 days)
The intended use of the Segaego 3D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.
Not Found
The provided text is an FDA 510(k) clearance letter for the "Scooter Segaego 3D," a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.
The letter primarily focuses on the regulatory aspects of the device, stating that it has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information from the provided text.
§ 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).