RADx Intraoral Appliance for Snoring and Sleep Apnea

RADx Intraoral Appliance for Snoring and Sleep Apnea is an FDA 510(k)-cleared medical device (K230532) manufactured by Achaemenid, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2023. Regulation: 8.