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510(k) Data Aggregation
(80 days)
The intended use of the Segaego 3D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.
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The provided text is an FDA 510(k) clearance letter for the "Scooter Segaego 3D," a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.
The letter primarily focuses on the regulatory aspects of the device, stating that it has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information from the provided text.
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