Following a warning letter from the Food and Drug Administration (FDA), Owlet has stopped selling its popular Smart Sock family in the US. On October 5th, the agency contacted Owlet to tell the company it was selling the wearables “without marketing approval, clearance or authorization.”
In a response spotted by Deseret News, Owlet says it’s complying with the FDA’s request. It has stopped selling the socks while it seeks clearance from the FDA. The company says it will offer a “new sleep monitoring solution” in the near future.
“With over one million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered,” the company said. “We will continue to stay focused on our mission and cooperate with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies.”
If you own the Smart Sock 3 or one of its predecessors, Owlet notes the FDA didn’t identify any safety with the wearables. It also hasn’t asked the company to issue a recall. Owlet says it will continue to support those products while it works on a new device.
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