Class I Medical device

class i device intelliprove has a ce marked medical device covering its core signal acquisition engine the technology that extracts physiological signals (e g , rppg) from facial video this ce marked device relates specifically to the validated signal extraction component the docid\ jmsmbxwfyqbsttsluvw00 and docid\ ll6fhdmodw8lce9xfduct are provided here about the face scan our commercially available wellness product, which includes the face scan, is powered by the same underlying technology however, the commercially available product is positioned and intended as a wellness solution and is not a medical device under eu mdr (2017/745), software qualifies as a medical device only if it has a medical intended purpose (article 2(1)) the currently available face scan product does not have such a medical intended purpose and is therefore not ce marked as a medical device furthermore, the face scan plug in displays values like hrv, subjective health questions, and goes beyond just measuring physiological signals it provides lifestyle oriented insights for self awareness and trend monitoring it does not provide diagnosis, therapeutic recommendations, or clinical decision support in your communication, it is important to therefore not refer to the face scan as a medical device, but as a wellbeing solution refer to the page docid\ am pn1lahv1w3siktdhfx , which applies to our commercially available product what this means for you you are using a wellness solution built on technology that has been developed and validated under medical device standards you benefit from the quality standards, clinical validation, and rigorous processes that come with medical device certification, but in a configuration that's appropriate and fully compliant for wellness applications