Trinity ELE Plus and Trinity ELE Plus Pro

Trinity ELE Plus and Trinity ELE Plus Pro is an FDA 510(k)-cleared medical device (K201906) manufactured by Carol Cole Company Dba Nuface. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2021. Regulation: 8.