MySleepDash

MySleepDash is an FDA 510(k)-cleared medical device (K252338) manufactured by Somnetics International, Inc. (Dba Transcend Inc). This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2026. Regulation: 8.