# 709755 (us_fda)

FDA Warning Letter MARCS-CMS 709755 (July 14, 2025). WHOOP MG Blood Pressure Insights feature marketed without FDA clearance.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_warning_letter
- Status: active
- Filing number: 709755
- Filing date: 2025-07-14
- Decision date: 2025-07-14
- Verification posture: verified
- Cap-flag notes: Uncleared feature. Warning letter, not clearance.

## Applicant

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

## Covered models (1)

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

## Sources (1)

- [https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025)

_Canonical URL: /regulatory-filings/whoop-fda-warning-letter-709755. HTML version: [/regulatory-filings/whoop-fda-warning-letter-709755](/regulatory-filings/whoop-fda-warning-letter-709755)._