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Electro-Cap Intl., Inc.
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ELECTRO-GEL is an FDA 510(k)-cleared medical device (K111717) manufactured by Electro-Cap Intl., Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2012. Regulation: 8.