(28 days)
This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.
Manual Folding Mobility Wheelchair
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves the device meets acceptance criteria.
The document is a letter from the FDA to Freedom Designs, Inc., regarding the substantial equivalence of their "Manual Folding Mobility Wheelchair." It primarily discusses regulatory aspects, such as classification, general controls, and marketing authorization. It does not contain any technical specifications, performance metrics, or details of a scientific study evaluating the device's performance against specific criteria.
§ 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).