(144 days)
The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons. The Breeze is also suite for the use of elderly persons and physically disabled persons.
Breeze C, 3&4 wheels Scooter
This is an FDA 510(k) clearance letter for a medical device (Breeze C, 3&4 wheels Scooter), not a study report or clinical trial
document. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study
details, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather
than proving performance against specific acceptance criteria through a clinical study as would be detailed in a separate
performance testing report or clinical trial submission.
Therefore, I cannot extract 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).