THE LUNG GYM (XLATOR AND NLATOR)

THE LUNG GYM (XLATOR AND NLATOR) is an FDA 510(k)-cleared medical device (K861564) manufactured by El-Fax Company, 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 August 6, 1986. Regulation: 8.