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Covidien
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SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE is an FDA 510(k)-cleared medical device (K100418) manufactured by Covidien. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 2010. Regulation: 8.