# fda_warning_letter (us_fda)

FDA Warning Letter (2025) to WHOOP regarding the Blood Pressure Insights (BPI) feature on WHOOP MG, marketed without FDA clearance for a blood-pressure medical claim.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_warning_letter
- Status: active
- Filing date: 2025-07-14
- Verification posture: verified
- Cap-flag notes: Enforcement action, not a clearance: the BPI feature is the verified-vs-claimed exemplar (manufacturer wellness framing vs FDA's medical-device reading).

## Applicant

- [Whoop](/companies/whoop.md)

## Covered models (1)

- [Whoop (5.0 / MG)](/models/whoop-mg.md)

## Sources (1)

- [https://www.fda.gov/medical-devices/warning-letters](https://www.fda.gov/medical-devices/warning-letters)

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