Owlet stops selling Sleep Sock after receiving warning from the FDA
(Gray News) - Owlet Baby Care, Inc. will discontinue selling its popular Smart Sock product after receiving a warning letter from the Food and Drug Administration.
The Smart Sock is a device that can be used to monitor and track a baby’s heart rate, oxygen level and sleep trends.
The FDA letter did not indicate any safety concerns about the product but said the Smart Sock is not in compliance with FDA guidelines.
The FDA told Owlet the Smart Sock should be classified as a medical device in the United States because of the heart rate and oxygen notifications it provides.
Owlet said in a response posted on its website that it plans to pursue marketing authorization from the FDA for those features.
“There has not been a request from the FDA to return or exchange any product at this time,” Owlet wrote in its response.
The company plans to offer the Dream Sock, a new sleep monitoring solution, in the U.S. sometime in January 2022.
“We will continue to stay focused on our mission and are cooperating with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies,” Owlet said.
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