The Owlet Smart Sock—which monitors a baby's heart rate, oxygen level, and sleep trends—has not been labeled a medical device by the FDA, which means the company must pursue marketing authorization for certain features.

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A popular baby monitor is being pulled after the U.S. Food and Drug Administration (FDA) noted that it is, indeed, a medical device but has not been authorized as such. The company that manufactures the Owlet Smart Sock—a device that's wrapped around a baby's foot and tracks the child's heart rate, oxygen level, and sleep trends—has been flagged by the FDA for breaking federal guidelines.

The issue hinges on the fact that the FDA sees the sock as a medical device. In a statement posted to the Owlet website, the company explains, "Owlet received a Warning Letter from the FDA regarding the Smart Sock's regulatory status in the United States. The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications. Based on the FDA's recent letter, Owlet plans to pursue marketing authorization from the FDA for these features."

They note that while they submit a device application to the FDA, they'll no longer be selling the Smart Sock.

"We plan to offer a new sleep monitoring solution, which we believe will be available soon," explains the company. "We also plan to continue to support our current customers."

The company emphasizes that for parents who already own and use the Smart Sock, "there's no change to your product's functionality or a request from the FDA to exchange or return your product at this time."

If there are any updates to the Smart Sock products that have already been distributed, the company plans to alert customers. "This action is specific to the U.S. only and no other countries or regions are affected by this," the statement adds.

Reassuring consumers of the Smart Sock's safety, the company shares, "The Smart Sock's safety has been validated by third parties, in which it was shown to be safe. In addition, the letter we received from the agency did not identify any safety concern about the Smart Sock."

More than one million monitors have been sold over the past six years, KSLTV reports.

By cooperating with the FDA, the company hopes to "continue to provide sleep monitoring products and solutions to parents and babies."

Consumers who have questions about the Smart Sock are encouraged to contact Owlet's Customer Service team (contact@owletcare.com or 844-334-5330 in the U.S.).