:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/UCKLZSZ64JDQNG4GBHTCQARHII.jpg)
A company has decided to stop selling a sock sold to help monitor a baby’s vital signs after receiving a warning letter from the Food and Drug Administration.
Owlet removed its “Smart Sock” from its website after the FDA sent the letter, which states the socks are medical devices that Owlet has sold without the FDA’s “marketing approval, clearance, or authorization,” Good Morning America reported.
The socks were designed to help parents track sleep patterns, but the FDA said that they were medical devices because they provided the baby’s heart rate and oxygen levels, USA Today reported.
In a letter posted on their website, Owlet said that while they are not selling the Smart Sock currently, they are pursuing marketing authorization from the FDA for their monitoring features. The company also promised a new sleep monitoring product, to be unveiled in January 2022.
©2021 Cox Media Group
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/F7WRDPMPZFBNHEFQ5XTYN5E6DU.jpg)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/GRZGPKEIUVHVFAVEGSOJSRA6JQ.jpg)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/JTVU2V6QZJDPJOFRLIAS3424MY.jpg)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/QWUTZPA7ABBMXDTHZKIAPGFRGM.jpg)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/QYS4IFSLUFA4FC4O22IHTQIBWE.jpg)