TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION is an FDA 510(k)-cleared medical device (K896787) manufactured by Saratoga Intl., Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 1990. Regulation: 8.