TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)

TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) is an FDA 510(k)-cleared medical device (K874469) 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 January 27, 1988. Regulation: 8.