Regulatory filing

709755 (us_fda)

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

fda warning letter · active · decided 2025-07-14

Track 709755 (us_fda)

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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

Covered models (1)

Whoop (5.0 / MG)

Sources (1)

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

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Identity

52116aa8-f38d-4849-8ae1-f07254eb74ed