(74 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Portable Wheelchair
The provided document is an FDA 510(k) clearance letter for a Portable Wheelchair (K243970). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications as typically associated with performance studies for AI/ML-driven medical devices or diagnostic tools.
This letter is a regulatory approval notice, not a clinical or technical study report. Therefore, I cannot provide the requested information based on the input text.
§ 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).