Is the Circular Ring a Medical Device?
The Circular Ring 2 is not classified as a medical device as a whole. However, it does include a medical-grade ECG algorithm and features that meet clinical standards for specific health monitoring.
✅ The Arrhythmia Detection Algorithm used with the ECG sensor is FDA-cleared, meaning it has passed a 510K validation for detecting irregular heart rhythms like atrial fibrillation, which is, substantially equivalent, to an FDA marketed device.
⚠️ That said, the ring itself is not currently certified as a medical device, and therefore, it is not intended to diagnose, treat, or cure any medical conditions. It’s designed to provide wellness insights, trends, and proactive indicators that you can discuss with a healthcare professional.
We are actively working on additional validations to expand medical-grade features in the future. Until then, Circular should not be a substitute for professional medical advice and devices.
If you're experiencing symptoms or need medical guidance, always consult a healthcare provider.
✅ The Arrhythmia Detection Algorithm used with the ECG sensor is FDA-cleared, meaning it has passed a 510K validation for detecting irregular heart rhythms like atrial fibrillation, which is, substantially equivalent, to an FDA marketed device.
⚠️ That said, the ring itself is not currently certified as a medical device, and therefore, it is not intended to diagnose, treat, or cure any medical conditions. It’s designed to provide wellness insights, trends, and proactive indicators that you can discuss with a healthcare professional.
We are actively working on additional validations to expand medical-grade features in the future. Until then, Circular should not be a substitute for professional medical advice and devices.
If you're experiencing symptoms or need medical guidance, always consult a healthcare provider.
Updated on: 28/03/2025
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