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Owlet revealed on October 4, 2021 that it had received a warning letter from the U.S. Food and Drug Administration (“FDA”), stating that “the Company’s marketing of its Owlet Smart Sock product . . . renders [it] a medical device requiring premarket clearance or approval from FDA.” Owlet has not obtained such clearance or approval. Moreover, the FDA “requests the Company cease commercial distribution of the Smart Sock for uses in measuring blood oxygen saturation and pulse rate where such metrics are intended to identify or diagnose desaturation and bradycardia using an alarm functionality to notify users that measurements are outside of preset values.”
On October 4, 2021, Owlet stock price fell as much as 23% during intraday trading on this news, thereby injuring investors.