Air Relax Pro Model AR-4.0

Air Relax Pro Model AR-4.0 is an FDA 510(k)-cleared medical device (K212491) manufactured by Diode Art Engineering Doing Business AS Air Relax. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2021. Regulation: 8.