PALS PLATINUM NEUROSTIMULATION ELECTRODES

PALS PLATINUM NEUROSTIMULATION ELECTRODES is an FDA 510(k)-cleared medical device (K132422) manufactured by Axelgaard Mfg. Co., 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 February 12, 2014. Regulation: 8.