{"id":"52116aa8-f38d-4849-8ae1-f07254eb74ed","slug":"whoop-fda-warning-letter-709755","filingNumber":"709755","filingType":"fda_warning_letter","jurisdiction":"us_fda","applicantCompanyId":"df3db3a4-f255-4eb2-b9a4-5f4e56a09ee7","filingDate":"2025-07-14T00:00:00.000Z","decisionDate":"2025-07-14T00:00:00.000Z","status":"active","clearanceScope":"FDA Warning Letter MARCS-CMS 709755 (July 14, 2025). WHOOP MG Blood Pressure Insights feature marketed without FDA clearance.","sources":[{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025","title":"WHOOP Inc Warning Letter 709755","sourceName":"FDA"}],"verificationPosture":"verified","capFlagNotes":"Uncleared feature. Warning letter, not clearance.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:26:48.591Z","updatedAt":"2026-07-15T02:26:48.591Z","applicantCompany":{"id":"df3db3a4-f255-4eb2-b9a4-5f4e56a09ee7","slug":"whoop","name":"Whoop"},"modelLinks":[{"id":"00e17b03-73c9-4b3a-8c32-b5b62b99c9ec","modelId":"82591feb-716d-4033-ae7e-611f253022cd","regulatoryFilingId":"52116aa8-f38d-4849-8ae1-f07254eb74ed","createdAt":"2026-07-15T02:26:49.515Z","model":{"slug":"whoop-mg","modelName":"Whoop (5.0 / MG)"}}]}