Shenzhen Ninenovo Technology Limited, the parent company of RingConn, said its smart ring has received 510(k) clearance from the U.S. Food and Drug Administration for non-invasive blood oxygen (SpO2) measurement. The clearance number is K260490.
The company said the device went through FDA regulatory review and was determined to be substantially equivalent to legally marketed predicate devices for non-invasive SpO2 measurement. According to the company, the clearance provides compliance assurance for its expansion into the U.S. healthcare and wellness market and strengthens its technical foundation in health monitoring applications for smart rings.
The company described SpO2 as a key physiological indicator of respiratory and circulatory function, and said continuous, convenient blood oxygen monitoring matters for daily health tracking and for watching physiological condition. RingConn uses PPG sensor technology and other developments to carry out the measurement, bringing monitoring into an everyday wearable form, and the company said it continues to conduct clinical research related to blood oxygen monitoring.
RingConn said it has so far obtained certifications including EU CE, U.S. FCC, Japan MIC, UK UKCA and Australia RCM, and that the product is available in more than 190 countries and regions. The company was established in 2021.
