SPRINGTMS TOTAL MIGRAINE SYSTEM

SPRINGTMS TOTAL MIGRAINE SYSTEM is an FDA 510(k)-cleared medical device (K140094) manufactured by Eneura Therapeutics, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 2014. Regulation: 8.