(85 days)
The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.
Model HP-3, Power Wheelchair
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair (Model HP-3). This document does not contain the information requested for acceptance criteria and study details for a medical device's performance.
The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls, but not specific performance criteria or a study demonstrating achievement of those criteria.
Therefore, I cannot extract the requested information from this document.
§ 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).