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510(k) Data Aggregation
(682 days)
DYNA T-2000 PHYSICAL THERAPY SYSTEM
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DYNA T-2000 Physical Therapy System
This document is a 510(k) clearance letter from the FDA for a device called the DYNA T-2000 Physical Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain the information required to answer your questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, often in sections detailing performance data and clinical studies, which are not part of this clearance letter.
Therefore, I cannot provide the requested details based solely on the provided text.
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