PATI (Protector Against Tongue Injury)

PATI (Protector Against Tongue Injury) is an FDA 510(k)-cleared medical device (K221469) manufactured by Neurovice, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 2023. Regulation: 8.