(216 days)
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.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.