(53 days)
The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions
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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.