SAM 3.0 Multi-Hour Continuous Ultrasound Device

SAM 3.0 Multi-Hour Continuous Ultrasound Device is an FDA 510(k)-cleared medical device (K260076) manufactured by ZetrOZ Systems, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2026. Regulation: 8.