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Owlet Baby Care, Inc. was warned for marketing the Owlet Smart Sock Family (versions 1, 2, 3, Smart Sock Plus, and co-packaged products) without required FDA marketing clearance or approval. The devices, which measure blood oxygen saturation and pulse rate to diagnose desaturation and bradycardia, were classified as adulterated under federal law because the company lacked either an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE). The FDA documented that the company was actively selling these products on multiple commercial websites, including Amazon, without any valid marketing authorization as of July 2021.