(283 days)
The EM-PROBE is 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, muscle spasm, and to increase local blood circulation.
EM-PROBE
The provided text is a 510(k) premarket notification letter from the FDA to EM PROBE, Inc. regarding their device, EM-PROBE. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or direct comparative effectiveness against human readers.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided text. The document is primarily a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, not a study report.
§ 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.