{"id":"b5c3936a-9ce6-4336-96cf-f829f6e18da8","slug":"fda-warning-letter-whoop-mg-bpi","filingNumber":null,"filingType":"fda_warning_letter","jurisdiction":"us_fda","applicantCompanyId":"df3db3a4-f255-4eb2-b9a4-5f4e56a09ee7","filingDate":"2025-07-14T12:00:00.000Z","decisionDate":null,"status":"active","clearanceScope":"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.","sources":[{"url":"https://www.fda.gov/medical-devices/warning-letters","title":"FDA Warning Letter - WHOOP Blood Pressure Insights (2025)","sourceName":"FDA (primary)"}],"verificationPosture":"verified","capFlagNotes":"Enforcement action, not a clearance: the BPI feature is the verified-vs-claimed exemplar (manufacturer wellness framing vs FDA's medical-device reading).","relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:09:23.147Z","updatedAt":"2026-06-05T15:35:56.018Z","applicantCompany":{"id":"df3db3a4-f255-4eb2-b9a4-5f4e56a09ee7","slug":"whoop","name":"Whoop"},"modelLinks":[{"id":"70218e42-7ec2-45a4-be61-7e727dbdeb31","modelId":"82591feb-716d-4033-ae7e-611f253022cd","regulatoryFilingId":"b5c3936a-9ce6-4336-96cf-f829f6e18da8","createdAt":"2026-06-04T23:09:23.304Z","model":{"slug":"whoop-mg","modelName":"Whoop (5.0 / MG)"}}]}