Owlet Shares Fall On FDA Warning Letter For Smart Sock

Owlet Inc 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.