Following a from the Food and Drug Administration (FDA), Owlet has stopped promoting its standard Smart Sock household within the US. On October fifth, the company contacted Owlet to inform the corporate it was promoting the wearables “without marketing approval, clearance or authorization.”
In a noticed by , Owlet says it’s complying with the FDA’s request. It has stopped promoting the socks whereas it seeks clearance from the FDA. The firm says it’s going to provide a “new sleep monitoring solution” within the close to future.
“With over one million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered,” the corporate mentioned. “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 personal the Smart Sock 3 or one in all its predecessors, Owlet notes the FDA didn’t determine any security with the wearables. It additionally hasn’t requested the corporate to challenge a recall. Owlet says it’s going to proceed to help these merchandise whereas it really works on a brand new system.
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