ActiGraph LEAP activity monitor (ActiGraph LEAP)

ActiGraph LEAP activity monitor (ActiGraph LEAP) is an FDA 510(k)-cleared medical device (K231532) manufactured by Actigraph, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2023. Regulation: 8.