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Advanced Cooling Therapy, Inc. D/B/A Attune Medical
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ensoETM is an FDA 510(k)-cleared medical device (DEN230021) manufactured by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 2023. Regulation: 8.