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Is the Owlet considered a medical device?

The Owlet Smart Sock is a consumer product that provides parents insights into their baby's wellness, as well as peace of mind each time the parent puts their child down for a nap or to sleep at night. 

The Owlet Smart Sock is not an FDA-approved medical device and is designed and intended for families with healthy infants. It is not meant to replace Safe Sleep Practices.


 

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