(30 days)
The intended use is to provide mobility to persons limited to a seated position.
Hoveround Teknique HD-6 Power Wheelchair
This document is a 510(k) premarket notification letter from the FDA for a power wheelchair, the Hoveround Teknique HD-6 Power Wheelchair. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It refers to regulations governing manufacturing practices, labeling, and adverse event reporting, but there is no mention of an algorithm or AI component, nor any performance study details as typically found for AI/ML devices.
Therefore, I cannot provide the requested information based on the provided 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).