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, relevant agencies contacted Owlet to tell the company it was selling the wearables “without marketing approval, permission or authorization.”
In a response discerned by Deseret News, Owlet says it’s complying with the FDA’s request. It has stopped selling the socks while it attempts clearance from the FDA. The company says it will render a “new sleep monitoring solution” in the near future.
“With over one million newborns checked, we are extremely proud of the innovation and technology Owlet has delivered, ” the company said. “We will continue to stay focused on our operation and cooperate with the FDA so we can continue to provide sleep monitoring produces and solutions to parents and babies.”
If you own the Smart Sock 3 or one of its precedes, Owlet records the FDA didn’t identify any security with the wearables. It also hasn’t questioned the company to issue a cancel. Owlet says it will continue to support those commodities while it works on a brand-new device.
Read more: engadget.com