(58 days)
To provide an optional means of mobility for physically challenged people.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Pillar Technology, Inc. regarding a device named "Glory." This letter confirms that the device has been found substantially equivalent to a predicate device for its stated indications for use: "To provide an optional means of mobility for physically challenged people."
However, this document does not contain any information about:
- Acceptance criteria or reported device performance.
- Study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set details.
The letter is a regulatory approval document and does not delve into the technical study details that would typically be found in a 510(k) submission. Therefore, I cannot generate the requested table and information based on the provided text.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).