Sensor Monitored Alimentary Restriction Therapy (SMART) Device

Sensor Monitored Alimentary Restriction Therapy (SMART) Device is an FDA 510(k)-cleared medical device (DEN150033) manufactured by Scientific Intake. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2016. Regulation: 8.