PERSONAL KINETIGRAPH (PKG) SYSTEM

PERSONAL KINETIGRAPH (PKG) SYSTEM is an FDA 510(k)-cleared medical device (K140086) manufactured by Gkc Manufacturing Pty, Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2014. Regulation: 8.