16 ch Tx/Rx Knee SPEEDER

16 ch Tx/Rx Knee SPEEDER is an FDA 510(k)-cleared medical device (K151753) manufactured by Quality Electrodynamics, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2015. Regulation: 8.