(21 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a manual wheelchair, indicating substantial equivalence to a predicate device. It does not contain any details about performance studies or clinical trials with the kind of metrics you've requested.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).