After obtaining certification from the Food and Drug Administration (FDA), Owlet stopped selling the popular Smart Sock family in the United States. On October 5, the agency contacted Owlet to tell the company that it was selling the wearable “without marketing approval, authorization, or licensing.”
in spotted Owlet says it is complying with the Food and Drug Administration’s request. She stopped selling socks while seeking approval from the Food and Drug Administration. The company says it will introduce a “new sleep monitoring solution” in the near future.
“With more than one million children monitored, we are incredibly proud of the innovation and technology Owlet has delivered,” the company said. “We will continue to focus on our mission and collaborate with the Food and Drug Administration so that we can continue to provide sleep monitoring products and solutions for parents and children.”
If you own the Smart Sock 3 or one of its predecessors, Owlet notes that the Food and Drug Administration has not identified any safety with wearable devices. Nor did it ask the company to issue a recall. Owlet says it will continue to support these products as it works on a new device.
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