Wellness compliance
How Wellex stays inside the wellness category and out of medical claims.
Last updated: 2026-04-07
The line
Wellex is a wellness device. It is not a medical device under any regulatory regime (FDA, MDR, MHRA, TGA).
What this means in practice
- We do not diagnose, treat, cure or prevent any disease.
- We do not provide medical advice.
- We do not market WVI as a clinical biomarker.
- We do not promise health outcomes.
What we do do
- Measure biometric signals accurately, with published validation.
- Compute a daily wellness index from those signals.
- Surface one daily action calibrated to the member's current state.
- Tell the member when to talk to a real clinician.
How partners stay compliant
If you are a Wellex partner recommending the product, do not say:
- "Wellex cures…"
- "Wellex prevents…"
- "Wellex is medically proven to…"
- "Wellex pays you / earns you money…"
You can say:
- "Wellex is a wellness bracelet that gave me a clear daily direction."
- "My HRV improved over 30 days of using it."
- "It helped me build a sleep habit."
Reporting
If you see a Wellex partner making medical claims or earnings claims, report it to [email protected].