iCE-SG2 Subcutaneous Electrode Kit

iCE-SG2 Subcutaneous Electrode Kit is an FDA 510(k)-cleared medical device (K222706) manufactured by Ice Neurosystems, 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 December 5, 2022. Regulation: 8.