Owlet stops selling infant monitoring sock after FDA order
After a warning letter from Food and Drug Administration (FDA), Owlet has stopped selling a popular Smart Sock family in the US. On October 5, the agency contacted the Owlet to notify the company that it sold that can be used “without marketing approval, permission or authorization.”
In the response seen by Deseret News, Owlet said it obeyed the request of the FDA. It has stopped selling socks while looking for permission from the FDA. The company said it would offer “new sleep monitoring solutions” in the near future.
“With more than one million babies monitored, we are very proud of innovation and technology flour that has been delivered,” said the company. “We will continue to focus on our mission and work with the FDA so that we can continue to provide product and sleep monitoring solutions for parents and babies.”
If you have Smart Sock 3 or one of its predecessors, the Cowlet records the FDA does not identify any security with what can be worn. It also hasn’t asked the company to remove memory. Owlet said it would continue to support the products while working on new devices.
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