Espire Elbow Pro, Espire Elbow Hybrid

Espire Elbow Pro, Espire Elbow Hybrid is an FDA 510(k)-cleared medical device (K182757) manufactured by College Park Industries, 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 November 28, 2018. Regulation: 8.