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Hydrogen Wellness™ products are marketed in the United States as general wellness devices under the FDA's General Wellness Policy for Low Risk Devices (updated January 2026). They are non-invasive, make no disease claims, and are not FDA-cleared or FDA-approved medical devices.

Hydrogen Wellness™ products are manufactured under ISO 13485 quality management system certification — the standard applied to medical device manufacture. ISO 13485 certifies the manufacturing system and process, not the device classification.

Hydrogen Wellness™ makes no claim that its products diagnose, cure, or prevent any disease or medical condition. The evidence library on hydrogenwellness.co presents educational summaries of published third-party research on molecular hydrogen — not product claims.

For US distributors, professional operators, and compliance teams: full regulatory documentation including the FDA General Wellness guidance reference, CE certificates, FCC certificates, and ISO 13485 certification is available on request.