FreedomEdge Syringe Infusion System

FreedomEdge Syringe Infusion System is an FDA 510(k)-cleared medical device (K214045) manufactured by Repro-Medical System, Inc., Dba Koru Medical Systems. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2022. Regulation: 8.