Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is an FDA 510(k)-cleared medical device (K233293) manufactured by Neurosigma, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2024. Regulation: 8.