ExsoMed ArcPhix and ExsoMed ArrowPhix

ExsoMed ArcPhix and ExsoMed ArrowPhix is an FDA 510(k)-cleared medical device (K171407) manufactured by Exsomed Holding Company, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 2017. Regulation: 8.