(25 days)
The intended use is to provide mobility to persons limited to a seated position.
Not Found
The provided text is a 510(k) premarket notification approval letter for the Hoveround E100 Powerchair. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance metrics for the device itself.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on the regulatory approval process and states the intended use of the powerchair, but does not include technical specifications, performance evaluation data, or ground truth details.
§ 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).