(89 days)
The ICL IR Heat Lamp Systems are intended 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 and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
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This document is a 510(k) premarket notification summary for an infrared lamp system. It establishes substantial equivalence to predicate devices but does not contain information about acceptance criteria or specific studies demonstrating device performance against such criteria.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and study data based on the provided text. The document focuses on regulatory approval based on equivalence, not on presenting performance data from studies.
The provided text does not contain:
- A table of acceptance criteria and reported device performance.
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§ 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.