(161 days)
The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "TUCO Erchonia PL3000" (though listed as PL2000 in the Indications for Use section). It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications. The letter primarily serves as a notification of clearance and refers to the device's substantial equivalence to a predicate device for its indicated use.
Therefore, I cannot fulfill your request for the detailed information asked for in points 1 through 9 based on the provided text. The document is a regulatory approval, not a scientific study report.
§ 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.