ALPHAONE BIOFEEDBACK SYSTEM

ALPHAONE BIOFEEDBACK SYSTEM is an FDA 510(k)-cleared medical device (K071661) manufactured by Telediagnostic Systems, 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 September 4, 2007. Regulation: 8.