RingConn's Smart Ring Gains FDA Clearance for Blood Oxygen Tracking
RingConn's wearable ring has received FDA 510(k) clearance to measure blood oxygen levels non-invasively.
RingConn, a wearable-tech firm headquartered in Shenzhen, announced that its Smart Ring has obtained FDA 510(k) clearance (No. K260490) for non-invasive blood oxygen (SpO2) measurement. The approval indicates the device is substantially equivalent to existing legally marketed products and can be marketed in the United States. The ring employs a photoplethysmography sensor to continuously track oxygen saturation, offering users health insights in a compact, finger-sized device.
RingConn said it is continuing clinical research to further substantiate the accuracy of its readings. This regulatory win follows a series of other certifications, including CE in Europe, FCC in the U.S., MIC in Japan, UKCA in the United Kingdom and RCM in Australia. Founded in 2021, the company now sells its products in over 190 countries and is targeting growth in the U.S. healthcare and wellness sectors.
Why it matters
FDA clearance lets the RingConn Smart Ring enter the U.S. market, expanding consumer access to continuous blood-oxygen monitoring.
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