ELECTRONIC PULSE STIMULATOR

ELECTRONIC PULSE STIMULATOR is an FDA 510(k)-cleared medical device (K131921) manufactured by Shenzhen Jingkehui Electronic 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 November 14, 2013. Regulation: 8.