(64 days)
The intended use of the MP3C is to provide mobility to adults, who have the capability to operate a few simple controls and the ability to control a power wheelchair.
MP3C Power Base Chair, Model MP3C
This document is a 510(k) clearance letter from the FDA for a power-operated chair, the "MP3C Power Base Chair, Model MP3C". It states that the device is substantially equivalent to legally marketed predicate devices.
This document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth, or an MRMC comparative effectiveness study.
The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.
§ 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).