{"id":"82591feb-716d-4033-ae7e-611f253022cd","companyId":"df3db3a4-f255-4eb2-b9a4-5f4e56a09ee7","modelName":"Whoop (5.0 / MG)","slug":"whoop-mg","description":"Whoop (founded 2012 in Boston by Will Ahmed) makes a biometric-primary, screen-free wrist band with strain, recovery, and sleep AI, recorded in the new biometric form factor and notable as the purest subscription-only model in the cohort, with no standalone hardware sale and annual memberships of $199, $239, and $359 that bundle the Whoop 5.0 and the Medical Grade Whoop MG launched May 8, 2025. It is the load-bearing verified-versus-claimed exemplar through a clean split on its MG device: its ECG is FDA-cleared via 510(k) K243236 on April 4, 2025 as an over-the-counter ECG classifying atrial fibrillation, sinus rhythm, and low and high heart rate for adults 22 and older, but its Blood Pressure Insights feature is not cleared and drew an FDA Warning Letter dated July 14, 2025, in which the FDA held that daily systolic and diastolic estimates are inherently associated with the diagnosis of hypertension and hypotension, meeting the device definition and requiring premarket clearance Whoop never obtained, warning that an erroneously low or high reading can have significant consequences. Whoop argues the feature is general wellness under the 21st Century Cures Act and refused to remove it after the compliance deadline passed, and as of May 21, 2026 the dispute remains unresolved with the feature still live and the warning letter now anchoring a class-action lawsuit, so the medical-grade branding applies defensibly only to the cleared ECG and not to blood pressure. A valuation correction is worth recording: Whoop is valued at $10.1 billion after a $575 million Series G in March 2026, not the stale roughly $3.6 billion figure from its 2021 Series F. Its clinical-validation posture is mixed and contested, with a real ECG clearance and study but a public regulatory finding against its blood-pressure marketing, and the blood-pressure accuracy and wellness classification, the Healthspan longevity construct, and the proprietary Strain and Recovery metrics are disputed or unverified.","formFactor":"biometric","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"THE verified-vs-claimed exemplar (the ECG-vs-BP split)","value":"ECG IS FDA-cleared: 510(k) K243236, cleared Apr 4 2025 (OTC ECG on Whoop MG; classifies AFib/sinus/low-HR/high-HR; 22+). Blood Pressure Insights is NOT cleared and is the load-bearing marketing-beyond-clearance case: FDA WARNING LETTER to WHOOP Inc dated Jul 14 2025 (CMS #709755) - FDA held that daily systolic/diastolic estimates are 'inherently associated with the diagnosis of' hypertension/hypotension, meeting the device definition + requiring premarket clearance Whoop never obtained ('An erroneously low or high blood pressure reading can have significant consequences')."},{"label":"Status + Whoop's contested defense","value":"Whoop argues BPI is a 'general wellness' feature under the 21st Century Cures Act and REFUSED to remove it; the FDA compliance deadline passed. As of May 21 2026 the dispute is UNRESOLVED (Whoop + FDA in discussions; BPI remains LIVE on the MG); the warning letter now anchors a class-action lawsuit. 'Medical-grade' branding applies defensibly only to the cleared ECG, not to BP."},{"label":"CORRECTION (valuation)","value":"Valuation is $10.1B (Series G $575M, Mar 2026; QIA/Mubadala) - NOT the stale ~$3.6B (that was the Aug 2021 Series F)."},{"label":"Verification posture","value":"Boundary: biometric-primary + AI-augmented (subscription model bundles the device). Clinical posture: MIXED/CONTESTED - ECG has a real 510(k) + study, but the BP warning letter is a public regulatory finding of marketing a diagnostic-grade metric without validation. NOT verified / disputed: BPI accuracy + its 'general wellness' classification (FDA rejects); 'Healthspan/Whoop Age' (proprietary longevity construct, no clinical validation); Strain/Recovery (proprietary, uncleared)."}],"specs":"Whoop 5.0 + Whoop MG ('Medical Grade'), both May 8 2025 (replaced 4.0); ~14-day battery. Sensors: PPG optical HR/HRV, skin temp, SpO2, respiratory rate. Analytics: Strain, Recovery, Sleep Coach; MG adds ECG + Blood Pressure Insights + Healthspan/'Whoop Age'. AI 'Whoop Coach' (LLM). Founded 2012, Boston (Will Ahmed). SUBSCRIPTION-ONLY: Whoop One $199/yr, Peak $239/yr, Life $359/yr (MG) - no standalone hardware sale.","formFactor":"biometric (biometric-primary screen-free wrist band; subscription-only; strain/recovery AI)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025","title":"FDA Warning Letter to WHOOP Inc (Jul 14 2025): Blood Pressure Insights marketed without clearance","sourceName":"FDA"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243236","title":"Whoop MG ECG FDA 510(k) K243236 (cleared Apr 4 2025; OTC ECG, AFib/sinus/low-HR/high-HR)","sourceName":"FDA (accessdata)"},{"url":"https://www.statnews.com/2026/05/21/whoop-fda-blood-pressure-dispute-unresolved/","title":"Whoop-FDA blood-pressure dispute unresolved (May 2026); BPI remains live; class action","sourceName":"STAT News"},{"url":"https://techcrunch.com/2026/03/31/whoop-raises-575m-series-g-10-billion-valuation/","title":"Whoop raises $575M Series G at $10.1B valuation (Mar 2026)","sourceName":"TechCrunch"}],"aliases":["Whoop MG","Whoop 5.0","Whoop 4.0","Whoop band"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T22:32:03.412Z","updatedAt":"2026-06-03T22:32:03.412Z","jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/whoop-mg","url":"https://registry.deploy.report/models/whoop-mg","name":"Whoop (5.0 / MG)","alternateName":["Whoop MG","Whoop 5.0","Whoop 4.0","Whoop band"],"description":"Whoop (founded 2012 in Boston by Will Ahmed) makes a biometric-primary, screen-free wrist band with strain, recovery, and sleep AI, recorded in the new biometric form factor and notable as the purest subscription-only model in the cohort, with no standalone hardware sale and annual memberships of $199, $239, and $359 that bundle the Whoop 5.0 and the Medical Grade Whoop MG launched May 8, 2025. It is the load-bearing verified-versus-claimed exemplar through a clean split on its MG device: its ECG is FDA-cleared via 510(k) K243236 on April 4, 2025 as an over-the-counter ECG classifying atrial fibrillation, sinus rhythm, and low and high heart rate for adults 22 and older, but its Blood Pressure Insights feature is not cleared and drew an FDA Warning Letter dated July 14, 2025, in which the FDA held that daily systolic and diastolic estimates are inherently associated with the diagnosis of hypertension and hypotension, meeting the device definition and requiring premarket clearance Whoop never obtained, warning that an erroneously low or high reading can have significant consequences. Whoop argues the feature is general wellness under the 21st Century Cures Act and refused to remove it after the compliance deadline passed, and as of May 21, 2026 the dispute remains unresolved with the feature still live and the warning letter now anchoring a class-action lawsuit, so the medical-grade branding applies defensibly only to the cleared ECG and not to blood pressure. A valuation correction is worth recording: Whoop is valued at $10.1 billion after a $575 million Series G in March 2026, not the stale roughly $3.6 billion figure from its 2021 Series F. Its clinical-validation posture is mixed and contested, with a real ECG clearance and study but a public regulatory finding against its blood-pressure marketing, and the blood-pressure accuracy and wellness classification, the Healthspan longevity construct, and the proprietary Strain and Recovery metrics are disputed or unverified.","identifier":"82591feb-716d-4033-ae7e-611f253022cd","category":"biometric","publisher":{"@id":"https://deploy.report/#organization"}}}