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Owlet Smart Sock banned by FDA

Owlet Smart Sock by Owlet stop selling. These devices suppose to track a baby’s vital signs and sleep patterns. After receiving a warning letter from the Food and Drug Administration (FDA). In the first report by Deseret News, the FDA’s letter states that Owlet’s Smart Socks consider medical devices. As they provide heart rate and oxygen level notifications. And, the company has been selling without the proper “marketing approval, permission, or authorization” from FDA. Owlet has since removed its family of Smart Socks, as well as any bundles that include the device from its site.

“The Owlet Smart Sock family of products is currently unavailable”, the Owlet Smart Sock’s product page says. “Check back in the coming weeks to see the newest addition to the nest”. This news is posted on IT Tech. Owlet Smart Sock still appears to be available on other online marketplaces, like Bed Bath & Beyond, Amazon, and BuyBuyBaby, for the time being at least. Owlet Smart Sock will still be available for purchase outside of the US.

Owlet Smart Sock

The FDA explains that Smart Socks are medical devices. Specifically, because they estimate blood oxygen saturation. And, heart rate with the strategy to “identify (diagnose) desaturation and provide an alarm to notify users. That measurements are outside present values.” As said in the letter, Owlet previously asserted that its Smart Socks are low-risk products, not medical devices. The FDA has apparently been notifying the brand that this is not the case since 2016.

Owlet’s Response to the FDA

Owlet Smart Sock 2

Owlet posted a response to the FDA on its site, nothing that it plans on complying with the FDA’s request. And, will seek marketing approval for its features that track heart rate and blood oxygen levels. The company also states that FDA did not identify any safety concerns about the Smart Sock. And, reassures existing sock owners that “there has not been any change” to its functionality. Owlet also hints at introducing a new, similar product in its letter, stating that it plans on offering a new “sleep monitoring solution“, which will be available “soon”.

Smart Baby Monitors, like Smart Socks, were condemned in the past. Doctors have suggested that they may honestly put babies at risk. Due to the fact that they are not classified as medical devices. And, are not subject to certain restrictions and supervision. “The Smart Sock’s safety inspects by third parties, in which it reveals to be safe”, Owlet claims in its post. “In addition, the letter we received from the agency, the FDA did not identify any safety concern about the Smart Sock“.

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