Shenzhen-based wearable technology company RingConn has received US Food and Drug Administration (FDA) 510(k) clearance for non-invasive blood oxygen (SpO2) measurement on its Smart Ring.
The clearance (No. K260490) means the device has undergone FDA regulatory review and has been found substantially equivalent to legally marketed predicate devices for non-invasive blood oxygen monitoring.
The approval marks a significant milestone for RingConn as it expands its presence in the US healthcare and wellness market, while strengthening its position in the growing smart ring sector.
Blood oxygen saturation, known as SpO2, is an important indicator of respiratory and circulatory health. Continuous monitoring can provide users with insights into their overall wellbeing and physiological condition, making it a sought-after feature in wearable health devices.
RingConn's Smart Ring uses photoplethysmography (PPG) sensor technology to measure blood oxygen levels non-invasively, bringing health-tracking capabilities to a compact, ring-sized form factor. The company said it is also continuing clinical research related to blood oxygen monitoring to support further validation of the technology.
The FDA clearance adds to a growing list of certifications obtained by the company, including CE certification in Europe, FCC approval in the US, MIC certification in Japan, UKCA certification in the UK and RCM certification in Australia.
Founded in 2021, RingConn says its products are now available in more than 190 countries and regions worldwide.