Owlet pulls Smart Sock from market
By HME News Staff
Updated 9:34 AM CST, Thu December 2, 2021
YARMOUTH, Maine – Owlet has halted sales of its Smart Sock vital sign monitors for babies after the U.S. Food and Drug Administration said the devices were improperly brought to market.
In a recent warning letter, the FDA said the company has sold the product, which it characterizes as a medical device because it provides heart rate and oxygen levels, without proper “marketing approval, clearance, or authorization” from the FDA.
“As a result of the letter and in light of our plans to submit a device application to the FDA, we will no longer be selling the Smart Sock,” said Owlet in a letter posted to its website. “We plan to offer a new sleep monitoring solution, which we believe will be available soon. We also plan to continue to support our current customers.”
Owlet pointed out the FDA didn't “identify any safety concerns about the Smart Sock,” and claimed the safety of the socks had "been validated by third parties, in which it was shown to be safe."
The company said it would notify customers of any updates to Smart Socks products that have already been distributed.
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