Kehoe Law Firm, P.C. is investigating whether Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT) violated federal securities laws.
During the morning of October 4, 2021, Owlet stock fell more than 30%, on the news that the Company notified investors that Owlet received an FDA warning letter concerning the improper marketing of its Smart Sock medical device product.
The Company stated in an SEC filing that “[o]n October 1, 2021, Owlet . . . received a Warning Letter, dated October 1, 2021 (the ‘Warning Letter’), from the United States Food and Drug Administration (‘FDA’).”
The Warning Letter asserts that the Company’s marketing of its Owlet Smart Sock product (the ‘Smart Sock’) in the United States renders the Smart Sock a medical device requiring premarket clearance or approval from FDA, and that the Company has not obtained such clearance or approval in violation of the Federal, Food, Drug, and Cosmetic Act. The Warning Letter requests that the Company take prompt action to address the alleged violations. Among other things, the Warning Letter 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. The Warning Letter also identifies certain marketing claims that FDA believes render the Smart Sock a medical device.