Regulatory compliance

X-trodes products via EMOTIV are intended to be used for research applications and personal use only. The products are not sold as Medical Devices and are not intended to be used for diagnosis or treatment of disease. 

The X-trodes system has been tested during internal testing, verification, and validation as well as human clinical testing to assure product safety, effectiveness, and reliability according to the requirement specifications and intended use.

External accredited test laboratories were used to conduct testing needed to comply with the applicable standards regarding Electromagnetic Compatibility (EMC) and patient safety.

The X-trodes device complies with the following standards:

EMC EN 55032:15+A1:20+A11:20 EN 55035:17 +A11:20 EN 61000-3-2:14 EN 61000-3-3:13+A1:19 EN 301 489-1:V2.2.3:19 EN 301 489-17 V3.2.4:20 47 CFR part 15 Sub B ICES-003:07

Safety IEC 62368-1 (Ed.3)- CB certificate - US/Canada

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