RingConn Smart Ring Receives FDA 510(k) Clearance for Non-Invasive Blood Oxygen Monitoring in U.S. Market
Shenzhen Ninenovo Technology Limited, the parent company of RingConn, has announced that its Smart Ring has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance specifically pertains to the non-invasive measurement of blood oxygen (SpO2) using the device. The FDA's determination signifies that the RingConn Smart Ring is substantially equivalent to legally marketed predicate devices for this function. This regulatory approval is a significant step for RingConn, enabling its expansion into the U.S. healthcare and wellness market. The device utilizes PPG sensor technology to integrate professional-grade blood oxygen monitoring capabilities into a wearable form factor. RingConn is also actively engaged in ongoing clinical research to further validate its blood oxygen monitoring data. The company has previously obtained various international certifications, including EU CE, U.S. FCC, Japan MIC, UK UKCA, and Australia RCM, and its product is available in over 190 countries an...
