Alio Medical Remote Monitoring System

Alio Medical Remote Monitoring System is an FDA 510(k)-cleared medical device (K211365) manufactured by Graftworx, Inc. Dba Alio. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2022. Regulation: 8.