(179 days)
This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls. The device has similar features and uses as the predicated devices; "Jazzy" (K945936) Electric Powered Wheelchair manufactured by Pride Health Care. This device has the same intended use, safety and effectiveness as the predicated device mentioned.
This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls.
The provided text is a 510(k) clearance letter from the FDA for a device named "Corsaire." It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document only states that the device is substantially equivalent to a predicate device ("Jazzy" K945936) and can be marketed.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).