Valleylab REM Polyhesive Infant Patient Return Electrode

Valleylab REM Polyhesive Infant Patient Return Electrode is an FDA 510(k)-cleared medical device (K160290) manufactured by Covidien, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2016. Regulation: 8.