Technology manufacturer Shenzhen Ninenovo received 510(k) regulatory clearance from the US Food and Drug Administration for non-invasive blood oxygen tracking on its RingConn smart ring.
, /PRNewswire/ -- Shenzhen Ninenovo Technology Limited, the parent company of RingConn, announced that its Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for non-invasive blood oxygen (SpO2) measurement (Clearance No. K260490).
This clearance marks a significant milestone for RingConn in the FDA-cleared wearable health device space. RingConn has undergone FDA regulatory review and has been determined to be substantially equivalent to legally marketed predicate devices for non-invasive measurement of blood oxygen (SpO2). This clearance provides compliance assurance for RingConn's expansion into the U.S. healthcare and wellness market, and further strengthens its technical foundation in health monitoring applications for smart rings.
Blood oxygen (SpO2) is a key physiological indicator of respiratory and circulatory function, and continuous, convenient blood oxygen monitoring is of great significance for daily health tracking and physiological condition monitoring. RingConn uses PPG sensor technology and other advancements to achieve non-invasive blood oxygen (SpO2) measurement, integrating professional-grade monitoring capabilities into an everyday wearable form factor. RingConn continues to conduct clinical research related to blood oxygen monitoring, building a solid data foundation for clinical validation of the product.
To date, RingConn has obtained multiple international authoritative certifications, including EU CE, U.S. FCC, Japan MIC, UK UKCA, and Australia RCM. The product is available in more than 190 countries and regions worldwide.
By PR Newswire
Ninenovo
RingConn