Baby tech company Owlet has pulled its connected-sock wearables from the market following an October FDA warning letter that the company was out of regulatory compliance. The news, which was first spotted by Deseret News, comes less than a year after the company went public.
The sock in question was designed to track an infant’s heart rate, skin temperature, blood oxygenation and sleep data. Currently the Owlet Smart Socks do not have marketing approval or clearance from the FDA. However, in the warning letter, the agency said that the company is currently marketing the product as a “diagnosis” tool, which would mean it needs a 510(k) clearance.
Specifically, the FDA said that the baby socks “are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. 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.”
According to the warning, the FDA has been in correspondence with Owlet