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Owlet Baby Care has stopped selling its smart socks, which can monitor babies’ sleep patterns. Six years after the product is on the market, it should receive a warning letter from federal health officials.
The U.S. Food and Drug Administration (FDA) notified the company in October that the product was sold as a medical device without federal agency approval.
According to its version of its website for consumers in another country, Owlet Smart Socks is described as being able to track children's heart rate, oxygen levels and sleep trends, which can be read in real time using the company's Owlet app.
According to the website, these socks are sold to children under 5 years of age. The product is no longer available on the website of American consumers.
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In the warning letter, the FDA stated that Owlet violated the Federal Food, Drug, and Cosmetic Act by selling the product in the United States "without marketing permission or approval." According to the FD&C Act, “These products are devices because they are designed to diagnose diseases or other conditions, or to cure, alleviate, treat, or prevent diseases, or affect the structure or any function of the body,” the FDA wrote.
The FDA stated that since 2016, it has been informing the company that Owlet Smart Sock is considered a device under the FD&C Act and “is not a compliance policy for low-risk products that promote a healthy lifestyle”.
Owlet Smart Sock advertises on its Australian website. (Owlet Care.com.au)
Owlet previously admitted that it received a letter from the agency on October 4 stating that since its establishment, it has been “focusing on the well-being of babies and the empowerment of parents” and is proud of the technology reported to have been used. Has more than 1 million babies.
At the time, the company also claimed that the product had been evaluated in a third-party research and proved to be safe.
In addition, the company's website explains that Owlet products are not medical devices.
"They are not intended to be used as medical devices or alternative medical devices. They will not and will not be used to diagnose, cure, treat, alleviate or prevent any disease or health condition, or to investigate, replace or modify anatomy or any physiological process, "The disclaimer reads.
However, the FDA in the warning letter required the company to "stop any activities that lead to adulteration," all versions of products and co-branded products.
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A spokesperson for Owlet told FOX Business in a statement that the letter "was not from the agency that found any security issues related to Smart Sock."
Despite this, Owlet confirmed that it will stop selling the product due to this letter and its plan to submit a device application to the FDA. Instead, Owlet plans to provide a new sleep monitoring solution, which is expected to be launched soon.
The company stated that it plans to "continue to support our existing customers" and will notify customers of "any updates to Smart Sock products that have been distributed."
The company also reiterated that these actions only affect US customers, and other countries or regions are not affected by this.
Owlet said in a statement: "Six years after the launch, four versions have been launched and more than 1 million babies have been monitored. We are very proud of the innovation and technology that Owlet provides." "We will continue to focus on our mission. And cooperate with the FDA so that we can continue to provide sleep monitoring products and solutions for parents and babies."
Quotes are displayed in real time or delayed for at least 15 minutes. Market data provided by Factset. Supported and implemented by FactSet Digital Solutions. Legal Notices. Mutual fund and ETF data is provided by Refinitiv Lipper.
Do not publish, disseminate, adapt or redistribute this material. ©2021 FOX News Network Co., Ltd. all rights reserved. Frequently Asked Questions-New Privacy Policy