Shenzhen Ninenovo Technology Limited, the parent company of RingConn, has announced that its RingConn smart ring has received U.S. Food and Drug Administration (FDA) 510(k) clearance for non-invasive blood oxygen saturation (SpO2) measurement. The clearance is listed under number K260490.
The regulatory milestone strengthens RingConn’s position in the wearable health technology market. Following its review, the FDA determined that the device is substantially equivalent to legally marketed predicate devices for non-invasive SpO2 measurement.
This clearance supports RingConn’s efforts to expand within the U.S. healthcare and wellness market while reinforcing the technological foundation of its smart ring health-monitoring capabilities.
RingConn Smart Ring Adds Blood Oxygen Monitoring
Blood oxygen saturation, commonly referred to as SpO2, is an important physiological indicator associated with respiratory and circulatory function. Convenient blood oxygen monitoring can help users track this measurement as part of their everyday health-monitoring routines.
The RingConn smart ring uses photoplethysmography (PPG) sensor technology, alongside other technical advancements, to measure blood oxygen levels without invasive procedures. Its compact wearable design brings SpO2 monitoring into a device intended for everyday use.
RingConn also continues to conduct clinical research related to blood oxygen monitoring. According to the company, this work is helping build a stronger data foundation for the product’s clinical validation.
RingConn Expands Its International Regulatory Credentials
In addition to its FDA 510(k) clearance, RingConn reports holding several international certifications and regulatory approvals. These include the European Union’s CE marking, U.S. Federal Communications Commission (FCC) certification, Japan’s Ministry of Internal Affairs and Communications (MIC) certification, the United Kingdom’s UKCA marking and Australia’s Regulatory Compliance Mark (RCM).
The company says its product is available in more than 190 countries and regions worldwide.
The latest clearance represents a further step in RingConn’s development of wearable health-monitoring technology, particularly in the area of non-invasive blood oxygen measurement.
