RingConn Receives FDA Clearance for Blood Oxygen Measurement
RingConn's Smart Ring has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for non-invasive blood oxygen (SpO2) measurement.
Shenzhen, China – 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 step for RingConn in the FDA-cleared wearable health device sector.
The FDA determined that the RingConn device is substantially equivalent to legally marketed predicate devices for non-invasive blood oxygen measurement. This approval facilitates RingConn's expansion into the U.S. healthcare and wellness market and reinforces its technical capabilities in health monitoring applications for smart rings.
Blood oxygen (SpO2) is a key physiological indicator of respiratory and circulatory function. Continuous and convenient monitoring of blood oxygen levels is significant for daily health tracking and physiological condition surveillance. RingConn utilizes PPG sensor technology and other advancements to achieve non-invasive SpO2 measurement, integrating professional-grade monitoring into an everyday wearable form factor.
The company has previously obtained multiple international certifications, including EU CE, U.S. FCC, and Japan MIC. RingConn products are available in over 190 countries and regions worldwide.