(258 days)
LED Stimulation for therapeutic heat
The NeurolumenPN is 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
TENS Stimulation
The symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
NeurolumenPN System, Model 1000
The provided text is a 510(k) premarket notification letter from the FDA regarding the NeurolumenPN device. This document confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
Therefore, I cannot provide the requested table and study details. The document is primarily an FDA communication approving the marketing of the device, not a technical report on its performance or the studies conducted for that purpose.
§ 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.