(619 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
I am sorry, but the provided text from the FDA letter does not contain information about an AI/ML medical device, its acceptance criteria, or any associated study details. The letter is a 510(k) premarket notification clearance for an electric scooter (Solax Electric Scooter Models S3121 and S312131), categorizing it as a Class II medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The document discusses regulatory aspects of device marketing, such as general controls, registration, listing, labeling, and good manufacturing practices, but it does not delve into performance metrics or study designs typically associated with AI/ML diagnostic or prognostic devices.
§ 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).