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Axelgaard Mfg. Co., Ltd.
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ULTRASTIM ELECTRODE, MODEL US4040 is an FDA 510(k)-cleared medical device (K000947) manufactured by Axelgaard Mfg. Co., Ltd.. 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 15, 2000. Regulation: 8.