DISPOSABLE PRE-GELLED SURFACE ELECTRODE

DISPOSABLE PRE-GELLED SURFACE ELECTRODE is an FDA 510(k)-cleared medical device (K142159) manufactured by Rochester Electro Medical, 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 June 2, 2015. Regulation: 8.