(142 days)
To provide an optional means of mobility for physically challenged people.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Coach 888," which is a "Motorized three-wheeled vehicle." This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor any clinical performance data.
Therefore, I cannot provide the requested information based on the input text. The text does not describe an AI/ML device or its performance characteristics. It simply confirms that the Coach 888 device is substantially equivalent to legally marketed predicate devices and can proceed to market.
§ 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).