Owlet Baby Care was a company that offered a wearable smart sock product designed to monitor an infant's vital signs, including heart rate and oxygen levels, while sleeping. The Owlet Smart Sock utilized pulse oximetry technology and a heart rate sensor to track the baby's breathing patterns and identify any potential interruptions or irregularities. Data collected by the sock was wirelessly transmitted via Bluetooth to a mobile app on the parents' smartphones, alerting them to any concerning readings.
Owlet invested significant resources in product safety testing, such as biocompatibility studies, FCC testing, and third-party accuracy studies submitted to the FDA as part of their 510(k) application for a medical version of the product. The company claimed that the Owlet Smart Sock used similar technology and provided comparable information to wearable devices like Apple Watch and Fitbit.
In November 2021, the FDA issued a directive requiring Owlet to remove its baby monitoring products from the market in the US due to safety concerns. Prior to this, Owlet had offered a Connected Care service, which provided historical data, sleep trends, and the ability to share information instantly with healthcare providers. The company had plans to release a new sleeping product.
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