Regulatory filing
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.
fda warning letter · active
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-warning-letter-whoop-mg-bpi.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/b5c3936a-9ce6-4336-96cf-f829f6e18da8
- Revision history: /regulatory-filings/fda-warning-letter-whoop-mg-bpi/history
- Data documentation: /data
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
Covered models (1)
Sources (1)
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Identity
b5c3936a-9ce6-4336-96cf-f829f6e18da8