TENS/NMES/FES STIMULATING ELECTRODE

TENS/NMES/FES STIMULATING ELECTRODE is an FDA 510(k)-cleared medical device (K083350) manufactured by Covidien LP. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2009. Regulation: 8.