Express 4 Sleep appliance/CPAP Sidekick appliance

Express 4 Sleep appliance/CPAP Sidekick appliance is an FDA 510(k)-cleared medical device (K173856) manufactured by Moses Appliances, 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 June 25, 2018. Regulation: 8.