FDA 510(k) Summary Of Spry Health Loop System Remote Monitoring Device

On March 29, 2019, the U.S. Food and Drug Administration (FDA) issued this summary of its 510(k) marketing approval of the Spry Health Loop System remote monitoring device. The Loop System includes the Loop Band, a wrist-worn medical wearable combined with AI-powered clinical analytics, and the Loop Charging Station. The individual wears the rechargable Loop Band for periods of up to 24 hours; the band remotely tracks the wearer’s heart rate, pulse-oximetry (SpO2), and respiratory rate. During recharging, the data collected by the Loop Band is uploaded to the Spry Server for access by . . .