DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is an FDA 510(k)-cleared medical device (K912283) manufactured by Chalgren Enterprises, 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 March 15, 1992. Regulation: 8.