Regulatory information

Consumer health and wellness technologies may fall into different regulatory categories depending on intended use, risk profile, and marketing claims.

Products intended to diagnose, treat, cure, or prevent medical conditions are typically classified as medical devices and are subject to much stricter regulatory frameworks.

Neuvago is designed as a general wellness technology intended to support relaxation, stress management, and autonomic nervous system awareness. Because the device does not make medical claims and is not intended for medical treatment, it is positioned within the general wellness product category.

General wellness products are consumer technologies designed to support healthy lifestyle practices that contribute to overall well-being.

This category can include products related to relaxation, stress support, sleep routines, mindfulness, meditation, nervous system awareness, and broader wellness habits.

Neuvago is intended to complement these kinds of wellness practices and is not intended to replace professional medical care.

In the European Union, products are regulated based on intended purpose and risk profile. Medical devices must comply with the Medical Device Regulation (EU) 2017/745.

Because Neuvago devices are not intended for medical diagnosis or treatment, they are not positioned as medical devices under that framework.

Instead, Neuvago devices are intended to be manufactured and placed on the market in accordance with applicable consumer electronics and product safety requirements relevant to wellness technologies.

Even when a product is not classified as a medical device, manufacturers must still ensure that products meet applicable safety requirements.

For consumer wellness electronics, this may include areas such as electrical safety, electromagnetic compatibility, battery safety, environmental compliance, material suitability, technical documentation, and product traceability.

These frameworks help ensure that consumer wellness technologies operate safely under normal conditions of use.

Different regions may apply different regulatory approaches to consumer wellness technologies.

Manufacturers and distributors must ensure that products comply with applicable local requirements before entering markets such as the European Union, the United States, or other international jurisdictions.

This is one reason why clear intended use and disciplined product claims are so important.

Regulatory classification is strongly influenced by how a product is described and marketed.

Products that make medical claims may fall under medical device regulation even when the underlying technology is similar to that used in consumer wellness products.

Neuvago is marketed for general wellness purposes, including relaxation, stress support, and support for autonomic balance. It is not promoted as a therapy or medical treatment.

Scientific research related to vagus nerve stimulation, autonomic regulation, and stress physiology is widely discussed in academic literature.

Neuvago may reference such research for educational and informational purposes. However, references to scientific studies do not imply that the Neuvago device provides medical treatment or reproduces the same outcomes reported in research settings.

We believe scientific information should be presented with context and without overstating what a consumer wellness product is designed to do.

Consumers should use wellness technologies responsibly and in accordance with product instructions and safety guidance.

Individuals with existing medical conditions, implanted medical devices, or concerns regarding electrical stimulation technologies should consult a qualified healthcare professional before use.

Neuvago is committed to transparency, safety, and responsible product design.

Our goal is to build wellness technology that supports relaxation and nervous system awareness while staying aligned with applicable consumer product, safety, and compliance frameworks.