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Intelwave, LLC
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INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 is an FDA 510(k)-cleared medical device (K062068) manufactured by Intelwave, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2006. Regulation: 8.