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Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

Sanidad Thermal Far-Infrared Wave Lamp, AP-2018

This document is a 510(k) premarket notification approval letter from the FDA for the Sanidad Far-Infrared Wave AP-2018. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets or ground truth establishment.

The letter is a regulatory approval and merely outlines the "Indications for Use" for the device: "Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains."

To answer your request, I would need a different document, specifically the premarket notification submission itself or a summary of its contents, which would typically include the study details you are asking for. The provided document is an approval letter, not the study results.

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