(187 days)
To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.
Skylark Infrared Lamp, Models SD-956IR and SD-100IR
This looks like a 510(k) clearance letter for an infrared lamp, not a study report for a medical device with performance metrics. The provided document is an FDA clearance letter for a device, not a study describing acceptance criteria and performance data. Therefore, I cannot extract the requested information about device performance and study methodology.
§ 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.