Shenzhen Ninenovo Technology, RingConn’s parent company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its smart ring to measure blood oxygen saturation (SpO2) non-invasively.
The clearance marks a regulatory milestone for RingConn as it expands its presence in the US healthcare and wellness market, strengthening its position in wearable health monitoring technology.
Blood oxygen saturation is an important physiological indicator of respiratory and circulatory function. Convenient monitoring of SpO2 can support daily health tracking by providing insights into changes in physiological conditions.
RingConn uses photoplethysmography (PPG) sensor technology to measure blood oxygen levels without invasive procedures, integrating health monitoring capabilities into an everyday wearable device.
The company said it continues to conduct clinical research related to blood oxygen monitoring to build a stronger evidence base for the technology and support further clinical validation.
According to the company, the FDA’s 510(k) review determined that the device is substantially equivalent to legally marketed predicate devices for non-invasive blood oxygen measurement.
RingConn also holds several international certifications and approvals, including the EU CE marking, US Federal Communications Commission (FCC) certification, Japan’s Ministry of Internal Affairs and Communications (MIC) certification, the UK Conformity Assessed (UKCA) marking and Australia’s Regulatory Compliance Mark (RCM).
The product is available in more than 190 countries and regions worldwide, the company said.
