(242 days)
The intended use is to provide mobility to persons limited to a seated position
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a powered wheelchair, the Hoveround Teknique HD6 MKII. It confirms that the device is substantially equivalent to legally marketed predicate devices.
This type of document is not relevant for providing the requested information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/ML-based medical devices. The letter primarily focuses on regulatory approval based on equivalence to existing devices, not on detailed performance studies for novel algorithmic features.
Therefore, I cannot extract the information requested in the prompt from the provided 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).