Search Results
Found 2 results
510(k) Data Aggregation
(99 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
JI-EE Electric Scooter, Esthete ES 1
This document is a marketing clearance letter from the FDA for a medical device (JI-EE Electric Scooter, Esthete ES 1). It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information based on the given input, as it is not present in the document.
Ask a specific question about this device
(85 days)
The device is intended for medical purposes to provide mobility to persons restricted to u seated position.
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "JI-EE Electric Scooter, Elegance ES 3" and related administrative information. It does not contain any information regarding acceptance criteria, study details, performance metrics, or ground truth establishment for a medical device's performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
Ask a specific question about this device
Page 1 of 1