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[TECHNOLOGY] · United States, China · 3 sources

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RingConn smart ring receives FDA clearance for SpO2 measurement

Shenzhen Ninenovo Technology Limited, the parent company of RingConn, has announced that its RingConn Smart Ring has received FDA 510(k) clearance for non-invasive blood oxygen (SpO2) measurement. This regulatory milestone, under clearance number K260490, allows the wearable to be marketed for monitoring respiratory and circulatory function through SpO2 levels.

The device utilizes photoplethysmography (PPG) sensor technology to capture light signals through tissue to evaluate oxygen content in the blood. The FDA determined the smart ring to be substantially equivalent to legally marketed predicate devices. This clearance marks a significant development for the brand, which is noted as the first Chinese smart ring brand to obtain such FDA clearance for oxygen saturation measurement.

Entities

RingConn · Shenzhen Ninenovo Technology Limited · U.S. Food and Drug Administration