Air Relax Plus Model AR-3.0

Air Relax Plus Model AR-3.0 is an FDA 510(k)-cleared medical device (K211460) 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 May 24, 2021. Regulation: 8.