MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is an FDA 510(k)-cleared medical device (K250356) manufactured by Infobionic, 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 July 28, 2025. Regulation: 8.