Owl has closed its sale smart sock, a lightweight device that wraps around a child’s leg to monitor heart rate, blood oxygen levels, and sleep patterns, after receiving a warning letter from the U.S. Food and Drug Administration.
In the letter, the FDA said the smart sock should be classified as a medical device because of its heart rate and oxygen notifications. Notice on Owlet website, The company said it plans to submit an application to the FDA for these features.
Looking for Black Friday deals?
Don’t miss a minute of the action with our live coverage of Black Friday 2021 deals.
position, which was Reported by KSL TV on Wednesday, adds that the FDA did not identify any safety concerns with the Smart Sock, and Owlet will continue to support those who have already purchased baby monitors. At this time, the FDA has not requested that people return or exchange the Smart Sock, Owlett said.
Owlet launches the third generation of its baby-monitoring sock, earlier this year. It works with kids up to 5 years old or 55 pounds. this is Which aims to give parents peace of mind with alerts on everything from movement to sleep patterns to baby’s pulse.
Owlet continues to offer its baby-monitoring camera and personalized sleep training program in the US, and its smart sock is available in other regions. The company’s notice said it plans to introduce a new “sleep monitoring solution” in the US that “will be available soon.”
Owlett did not 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 to be health or medical advice. Always consult with a physician or other qualified health provider with respect to any questions you may have about a medical condition or health purposes.