ZEUS Platform (FG0501US)

ZEUS Platform (FG0501US) is an FDA 510(k)-cleared medical device (K252859) manufactured by iRhythm Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2026. Regulation: 8.