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Owlet Smart Sock 3rd Gen. 0-18 Months Heart Rate & Oxygen Monitor (BM06NNBBYG)

 

   Manufacturer Model Number:    Owlet Smart Sock 3rd Generation

                    Manufacturer P/N:     BM06NNBBYG

                   Owlet Smart Sock:     3rd Gen (0-18 months)

             

   

Product Features

      Disclaimer from the Manufacturer - Owlet is transitioning to new app experiences for Owlet Smart Sock and Cam users with iOS devices. As of November 22, 2021, the Owlet Care App is no longer available for download from the App store for iOS devices. Please reference this guide to identify the App compatible with your Owlet product(s) and smartphone platform.

      This does not impact Smart Sock and Cam users who have previously downloaded the Owlet Care App to their iOS devices, as the iOS app will remain tied to their Apple ID. It also doesn’t affect any users who have Android devices. The Owlet Care App remains available in the Google Play Store at this time. Only those with iOS devices, that had not yet downloaded the Owlet Care App, will be directly affected as they will be unable to download the app. It will also limit Owlet’s ability to make changes to (and push out updates for) the iOS Owlet Care App for users in the U.S. who downloaded it prior to the app’s removal from the Apple App Store. 

    The decision to transition to a new app is based on the U.S. FDA’s recent assertion in a Warning Letter that the Smart Sock is a medical device because of the heart rate and oxygen notifications it offered. It’s important to note the FDA’s letter did not call out any safety issues with the Smart Sock, and the FDA’s assertion only applies to the U.S. We have been working with the FDA and partners like Apple to transition to a new app and consumer wellness product that addresses FDA’s concerns. We will continue to share updates as we have more information.



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