Owlet smart monitoring socks will be stopped from sale after FDA warning!

Owlet Baby Care , a business that has been selling smart monitoring socks for nearly six years, recently received a notice from the U.S. Food and Drug Administration (FDA) in October that the product was sold as a medical device without approval from the federal agency.

According to a version of the company's website aimed at consumers in another country, the Owlet Smart Socks are described as being able to track a child's heart rate, oxygen levels and sleep trends, which can be read in real time through the company's Owlet app.

The FDA said Owlet violated the Federal Food, Drug, and Cosmetic Act by selling the product in the U.S. without marketing authorization or approval.

Such products are devices under the relevant statute 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, the FDA wrote in the warning letter .

The picture comes from Owlet official website

The FDA said it had been notifying the company since 2016 that the device did not meet its compliance policy for low-risk products that promote a healthy lifestyle. At the time, the company also claimed that the product had been evaluated in third-party studies and proven to be safe .

Additionally, the company's website explains that Owlet products are not medical devices.

Owlet wrote in its disclaimer that they are not intended to be used as a medical device or a substitute for a medical device. However, the FDA in its warning letter asked the company to stop any activities that lead to adulteration , including all versions of its products and co-branded products.

As a result of this letter and its plans to submit a device application to the FDA, Owlet will cease sales of the product. However , the company plans to offer a new sleep monitoring solution, which is expected to be launched soon.

The company reiterated that these actions will only affect its US customers and no other countries or regions .

It is understood that they have launched four versions and served more than 1 million babies. The company will invest more energy in the research and development of new products.

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