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FDA Warning Letter Prompts Company To Stop Selling Baby-Monitoring Device

 
• By Shawn M. Schmitt

For five years Owlet Baby Care Inc. has said its Smart Sock monitoring product isn’t a medical device. But the US FDA disagreed – and finally put its foot down in a warning letter that told the company to come into compliance or stop selling the sock. So Owlet decided to do both.

Owlet Smart Sock.
The Owlet Smart Sock • Source: Alamy

The Utah-based manufacturer of the Smart Sock baby monitor has stopping selling the product after receiving a warning letter from the US Food and Drug Administration that says the sock is a medical device and should be regulated as one.

The Smart Sock wraps around a baby’s foot and monitors the child’s heart rate, blood oxygen levels and sleep patterns.

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