(400 days)
The Action Trackstander all-terrain power wheelchair with the integrated stand-up position function provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and cannot stand up on their own. The Action Trackstander does not require a doctor's prescription.
Action Trackstander models Tr1816. Tr1820. Tr2016. and Tr2020
The provided document is an FDA 510(k) clearance letter for Action Manufacturing Inc.'s Action Trackstander power wheelchairs. It primarily concerns regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details. This document is a regulatory communication, not a scientific or clinical study report.
Therefore, I cannot fulfill your request for that specific information based on the provided text.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).