(221 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Not Found
This document is a FDA 510(k) clearance letter for an electrically powered wheelchair. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria, as one would find for a diagnostic or AI-enabled medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in performance testing reports, clinical study summaries, or validation reports, which are not part of this 510(k) clearance letter.
§ 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).