(103 days)
The Light-Force-Therapy line of infrared lamps are indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
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I am sorry, but the provided text does not contain the detailed information required to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. The document is primarily an FDA 510(k) clearance letter for an infrared lamp, confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include a study report or data on the device's performance against specific acceptance criteria.
§ 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.