(117 days)
The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Electric Powered Lift Wheelchair, Model Vision (P13)". This document describes the device, its intended use, and the FDA's marketing approval. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.
Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval process and not on the technical performance data that would typically be generated for a device study.
§ 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).