MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is an FDA 510(k)-cleared medical device (K201257) manufactured by Arrive Systems, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2021. Regulation: 8.