The Neurolumen device has not only been cleared once but twice. The FDA wanted to make sure that our clearance was appropriate for our device. And it was, but it allowed us the add to our indications.
Indications for use:
The Neurolumen is indicated for the 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.
The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142025.pdf
Neurolumen submitted to the FDA three modalities combine in one device. We incorporated low-level lasers, LEDs and electrical stimulation in an easy-to-use prescription device. The modalities were placed in a padded flexible wrap that can be wrapped and secured around an area, or a patient can lie on it.