Electromed SmartVest Airway Clearance System

Electromed SmartVest Airway Clearance System is an FDA 510(k)-cleared medical device (K222496) manufactured by Electromed, 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 November 17, 2022. Regulation: 8.