(28 days)
Power settings in the range of 5-50 Watts is 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, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Not Found
This document is a 510(k) clearance letter for the Palomar Medical Technologies Inc. ThermaPulse™ device, an infrared lamp. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) summary or the original submission itself, which are not provided here.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and substantial equivalence to a predicate device.
§ 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.