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Owlet stops selling smart sock for babies in US after FDA warning

The company says the device is safe and it'll continue to support current customers.

Owlet baby monitor
The Owlet Smart Sock measures heart rate, breathing and sleep trends.
Christopher Langlo/CNET

Owlet has stopped selling its Smart Sock, a lightweight device that wraps around a child's foot to monitor heart rate, blood oxygen levels and sleep patterns, after receiving a warning letter from the US Food and Drug Administration. 

In the letter, the FDA said the smart sock should be classified as a medical device due to its heart rate and oxygen notifications, according to a notice on the Owlet website. The company said it plans to submit an application to the FDA for these features. 

The post, which was reported by KSL TV on Wednesday, adds that the FDA didn't identify any safety concerns with the smart sock, and Owlet will continue to support people who've already purchased the baby monitor. At this time, the FDA hasn't requested that people return or exchange the smart sock, Owlet said.

Owlet launched the third generation of its baby-monitoring sock, the $359 Owlet Smart Sock Plus, earlier this year. It works with children up to 5 years of age or 55 pounds. It's among a growing field of smart baby monitor devices that aim to bring peace of mind to parents with alerts on everything from motion to sleep patterns to baby's vitals. 

Owlet continues to offer its baby-monitoring camera and personalized sleep training program in the US, and its smart sock remains available in other regions. The company's notice said it plans to offer a new "sleep monitoring solution" in the US, which will be "available soon."

Owlet didn't immediately respond to a request for additional comment. 

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.