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Pepin Mfg., Inc.
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COMFORT/IO IONTOPHORESIS ELECTRODES is an FDA 510(k)-cleared medical device (K060579) manufactured by Pepin Mfg., Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2006. Regulation: 8.