TRANSCUTANEOUS ELEC. NERVE STIMULATOR

TRANSCUTANEOUS ELEC. NERVE STIMULATOR is an FDA 510(k)-cleared medical device (K813501) manufactured by Empi. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 1981. Regulation: 8.