ELAN 4 Electro Motor System

ELAN 4 Electro Motor System is an FDA 510(k)-cleared medical device (K203739) manufactured by Aesculap, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 2021. Regulation: 8.