(118 days)
The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.
Electric Powered Scooter, Model SE03
{0} This document is a 510(k) premarket notification decision letter from the FDA to Sunpex Technology Company regarding their Electric Powered Scooter, Model SE03. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
This letter does not contain information about acceptance criteria or specific study results showing device performance. Instead, it is a regulatory document confirming the substantial equivalence determination for market approval. Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
This type of information is typically found in the 510(k) submission document itself, which is a detailed technical submission to the FDA, rather than the final decision letter.
§ 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).