ESCOTEK EST TRAC 401

ESCOTEK EST TRAC 401 is an FDA 510(k)-cleared medical device (K844385) manufactured by Nor-Am Patient Care Products, Inc.. 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 April 30, 1985. Regulation: 8.