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. because the company did not obtain proper Food and Drug Administration approvals.
According to Deseret News, the company received a warning letter from the FDA at the beginning of October, but apparently just stopped selling the monitoring devices recently. The FDA said that the Owlet Smart Socks were medical devices, but that the company had not applied for marketing clearance or approval. The company was asked to address its concerns by the agency.
Owlet addressed the agency's warning on its website and said it would seek the proper approvals. The company's Owlet Smart Socks and related products were not available for purchase on its website on Friday.
Owlet said that the FDA asserts that the Smart Sock should be classified as a medical device in the US because of the heart rate and oxygen notifications. We will let customers know if there are any changes to the products that have already been distributed.
Gizmodo reached out to Owlet on Friday to inquire about the specific date the company stopped selling its products and what plans it had to address the baby monitoring sock products still being sold by third-party retailers. We were able to find the products at Walmart and Amazon even though they were unavailable at Target.
The company didn't reply to our questions. The statement was published on Owlet's website.
Owlet will support customers who have already purchased its products. It said it would release a new sleep monitoring solution soon. The company said that no other country or region has forced it to take similar measures.
Owlet's Smart Socks are medical devices because they are intended for use in the diagnosis of disease or other conditions, as well as in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The FDA stated that the Owlet Smart Socks were low-risk products that promote a healthy lifestyle. That is not the case.
The agency wrote that products that measure blood oxygen saturation and pulse rate are devices when they are intended to identify desaturation and bradycardia.
The FDA told Owlet that its products were medical devices and not low-risk products that promote a healthy lifestyle.
Owlet reassured customers that the Smart Sock was safe and pointed out that the product's function has not changed. It said it would meet with the FDA to discuss the devices.
The Smart Sock was shown to be safe by third parties. Owlet said that the letter they received from the agency did not identify any safety concern about the Smart Sock.
