(80 days)
The intended use of the HP-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.
Model HP-5, Power Wheelchair
This document is a 510(k) clearance letter from the FDA for a power wheelchair, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device but does not detail studies or acceptance criteria for the Model HP-5.
§ 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).