Why can't I buy an Owlet Smart Sock?
Why the popular baby heart- and oxygen-monitoring device was pulled from the market
Once a baby registry favorite, the Owlet Smart Sock, a device worn on a baby's foot to monitor their vital signs, was forced off the market by the FDA in November of 2021. The FDA said the sock was being sold without the FDA’s “marketing approval, clearance, or authorization in violation of the Federal Food, Drug, and Cosmetic Act” since it was classified as a medical device by the FDA.
Owlet said in a response letter that the FDA “did not identify any safety concerns about the Smart Sock” and the company would create a sleep monitoring product instead, which is now available for sale as the Dream Sock ($300). The Dream Sock still monitors heart rate, average oxygen level, movement, and wakings and will alert parents but it is not marketed in a way that suggests it is a medical device.
Owlet states on its website that the Smart Sock can still be used and can be updated to the settings of the Dream Sock.
It's always important to consult with a pediatrician before using any device to monitor a baby's vital signs, especially if the child has any pre-existing health conditions.