(60 days)
The intended use of Travel Ease Electric Scooter, Pioneer 2 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Travel Ease Electric Scooter, Pioneer 2." It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a previously cleared device.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory clearance and substantial equivalence determination, not on detailed performance studies or acceptance criteria.
§ 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).