NEUROCALM MODEL 1 AND 2

NEUROCALM MODEL 1 AND 2 is an FDA 510(k)-cleared medical device (K090866) manufactured by Neuromed Devices, 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 October 20, 2009. Regulation: 8.