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510(k) Data Aggregation
(80 days)
The A&I Pediatric Wheelchairs are intended to provide mobility to persons, primarily children, who may be limited to a sitting position.
The A&I Bariatric Wheelchairs are intended to provide mobility to persons, primarily larger adults, who may be limited to a sitting position.
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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for wheelchairs. It confirms the substantial equivalence of the wheelchairs to previously marketed devices and outlines regulatory requirements.
This document does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria. It is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information.
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(35 days)
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