(219 days)
All four devices are indicated for 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 heat is indicated.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the MR4 Multi Radiance Therapy System and its accessories. This type of document establishes substantial equivalence to a predicate device and permits marketing. It outlines the regulatory classification and general controls.
However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
Specifically, the requested information about device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details is completely absent from the provided text.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input, as the necessary information is not present.
§ 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.