Owlet Baby Care’s family of popular baby monitoring socks, which claim to keep an eye on infants’ oxygen level, heart rate, and hours slept, can no longer be bought in the U.S. at this time because the company did not obtain proper Food and Drug Administration approvals for the products.
The company received a warning letter from the FDA at the beginning of October asking it to stop selling the monitoring devices, although it apparently just did so in recent days, according to Deseret News. In its letter, the FDA said that the Owlet Smart Socks were medical devices, but that the company had not applied for the appropriate “marketing clearance or approval.” The agency asked the company to address its concerns and correct them.
Owlet addressed the agency’s warning on its website in an undated response and said it planned to solicit the proper approvals. On Friday, the company’s Owlet Smart Socks and related products, such as the Smart Sock Plus and the Monitor Duo, were not available for purchase on its website.
“The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications,” Owlet said, adding: “There has not been any change to your product’s functionality or a request from the FDA to exchange or return your product at this time. We will notify customers of any updates to the Smart Sock products that have already been distributed.”
Gizmodo reached out to Owlet on Friday to ask about the specific date the company had stopped selling its products and what plans it had to address the baby monitoring sock products still being sold by third-party retailers. While the products were unavailable at Target, we were still able to find them online at Walmart and Amazon.
The company did not respond to our questions. A spokesperson sent us the published statement on Owlet’s website, part of which is included above.
Owlet will continue to support customers that have already bought its products. In addition, it said it planned to release a “new sleep monitoring solution” soon. The FDA’s decision only affects sales of the Owlet Smart Socks in the U.S. No other country or region has forced it to take similar measures, the company said.
According to the FDA, Owlet’s Smart Socks are medical devices because they are “intended for use in the diagnosis of disease or other conditions” as well as/or “in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.”
The company had maintained that the Owlet Smart Socks were low-risk products that promote a healthy lifestyle, the FDA stated, which would mean they did not require certain FDA clearances. But that is not the case.
“Products that measure blood oxygen saturation and pulse rate are devices when they are intended to identify (diagnose) desaturation and bradycardia and provide an alarm to notify users that measurements are outside preset values,” the agency wrote.
Notably, the FDA said it had been telling Owlet that its products were medical devices and not low-risk products that promote a healthy lifestyle since 2016.
In the question-and-answer section on its website, Owlet reassured customers that the Smart Sock was safe and pointed out that the product’s functionality has not changed. It also said it hoped to meet with the FDA soon to discuss the devices.
“The Smart Sock’s safety has been validated by third parties, in which it was shown to be safe. In addition, the letter we received from the agency did not identify any safety concern about the Smart Sock,” Owlet said.