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WHOOP, Inc. was cited for marketing Blood Pressure Insights (BPI), a medical device that provides daily systolic and diastolic blood pressure estimations, without obtaining required FDA premarket approval or an investigational device exemption. The company violated the Federal Food, Drug, and Cosmetic Act by failing to secure a PMA application or IDE authorization before commercializing the device, rendering it adulterated under section 501(f)(1)(B), and also failed to notify FDA of its intent to introduce the device into commercial distribution, violating misbranding requirements under section 502(o). FDA's review of WHOOP's website and marketing materials revealed the company explicitly marketed BPI as providing "medical-grade health & performance insights" intended to help users measure or estimate their blood pressure and understand its effects on sleep, recovery, and performance.