(111 days)
The KenkoWave Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Not Found
The provided document is a 510(k) clearance letter for the KenkoWave Infrared Treatment System. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. The letter focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the manufacturer to market the product.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications from this document. This letter 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.