• Owlet Inc (NYSE: OWLT) stock has dropped almost 24% in the trading session due to receiving a Warning Letter dated October 1, 2021, from the FDA.

• The Warning Letter asserts that the Company's marketing of its Owlet Smart Sock product in the U.S. renders the Smart Sock a medical device requiring premarket clearance or approval from FDA.

• But the Company has not obtained such clearance or approval.

• The Warning Letter requests the Company cease commercial distribution of the Smart Sock for use to measure blood oxygen saturation and pulse rate.

• Owlet positions the Smart Sock Plus as a way to monitor a child's well-being.

• The Letter also identifies certain marketing claims that FDA believes render the Smart Sock a medical device.

• In July, Owlet merged with Sandbridge Acquisition Corporation, a SPAC, to go public.

• Related content: Benzinga's Full FDA Calendar.

• Price Action: OWLT shares fell 23.6% to $4.19 on Monday.

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