(28 days)
The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.
Not Found
This document is a 510(k) clearance letter from the FDA for a powered wheelchair, the MP3CF. It declares substantial equivalence to a predicate device.
There is no information in the provided text regarding acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is strictly an FDA clearance letter.
Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed, subject to general controls and potentially additional special controls.
§ 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).