510(k) K844385

ESCOTEK EST TRAC 401 by Nor-Am Patient Care Products, Inc. — Product Code ITH

K844385 is an FDA 510(k) premarket notification submitted by Nor-Am Patient Care Products, Inc. for the device "ESCOTEK EST TRAC 401". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Nor-Am Patient Care Products, Inc. has 6 other 510(k) clearances on record.