Owlet Baby Care has received a warning letter from the Food and Drug Administration regarding their ...
Owlet Baby Care

Owlet Has Stopped Selling Its Smart Sock Baby Monitor After FDA Warning

The FDA claims Owlet’s marketing of the Smart Sock renders it a medical device, which the company has not received clearance for.

by Morgan Brinlee
Originally Published: 

Owlet, the company behind the popular Smart Sock, has ceased selling the baby sleep monitoring device following a warning from the U.S. Food and Drug Administration (FDA). In a warning letter sent last month, the FDA argued marketing claims rendered Owlet’s Smart Sock — a device that uses infrared light to monitor a baby’s heart rate and blood oxygen level — a medical device that needed premarket FDA approval. While Owlet has said it plans to apply for FDA approval, the company announced last week it had stopped selling the Smart Sock.

The FDA Sent Owlet A Warning Letter In October

Owlet said it received an official warning letter from the FDA on Oct. 1 in an SEC filing submitted earlier this month. “The Warning Letter asserts that the Company’s marketing of its Owlet Smart Sock product (the ‘Smart Sock’) in the United States renders the Smart Sock a medical device requiring premarket clearance or approval from FDA, and that the Company has not obtained such clearance or approval in violation of the Federal, Food, Drug, and Cosmetic Act,” the filing said.

Owlet’s Smart Sock, which was priced at $299, is marketed as an award-winning product that tracks “the most important indicators of your baby’s well-being” while they rest. It tracks heart rate, oxygen levels, and sleep trends and pairs with a smartphone app to alert caregivers or parents when a baby’s readings fall outside of preset zones.

In its letter to Owlet, the FDA requested the company stop commercial distribution of the Smart Sock for use in measuring blood oxygen saturation and pulse rate for the intended purpose of identifying or diagnosing desaturation and bradycardia via an alarm or notification function. The FDA also alerted Owlet to marketing claims made by the company, which the FDA argued rendered the Smart Sock a medical device.

Owlet Baby Care

Owlet Said It Plans To Fully Cooperate With The FDA

In its SEC filing, Owlet said it intended to cooperate fully with the FDA and would pursue a marketing authorization application for uses of the Smart Sock identified as being medical device uses but could not guarantee the FDA would be satisfied with its actions. Romper has reached out to Owlet for additional comment.

Despite Owlet’s willingness to work with the FDA on a solution, news of the federal agency’s warning caused Owlet Inc. stock to drop nearly 24% earlier this week. According to CNN’s Market Watch, Owlet only recently began trading shares in July following a merger with special-purpose acquisition company (SPAC) Sandbridge Acquisition Capital.

Owlet has placed a disclaimer on its website, which emphasized no Owlet product was a medical device nor intended to be used to “diagnose, cure, treat, alleviate, or prevent” any type of disease or health condition. “The Smart Sock is only intended to assist you in tracking your child’s well-being and is not intended to replace you as a caregiver,” the disclaimer read. “You are responsible for the health and well-being of your child and following safe sleep, health, and care guidelines.”

Owlet Has Since Stopped Selling The Smart Sock

Nearly two months after receiving the FDA’s warning, however, Owlet has ceased sales of the Smart Sock — for now at least. “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,” the company said in a statement shared last week with KSL-TV. “We plan to offer a new sleep monitoring solution, which we believe will be available soon.”

As of Monday, the Smart Sock could no longer be purchased directly from the Owlet website. The device was, however, available for purchase via third-party retailers like Buy Buy Baby and Bed Bath and Beyond.

In announcing its decision to stop selling the Smart Sock, Owlet stressed it was “extremely proud” of the innovation and technology it had delivered to parents and caregivers and said the company had no plans to abandon its commitment to providing sleep monitoring solutions. “We will continue to stay focused on our mission and are cooperating with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies,” KSL-TV reported the company said.

What Should You Do If You Have A Smart Sock?

While Owlet has ceased sales of the Smart Sock, customers who already own the device don’t need to abandon it completely. The company has said it plans to continue supporting current U.S. customers by notifying them of any updates to already-distributed Smart Sock products.

In a note on its website, however, Owlet warned that beginning Nov. 22, the Owlet Care App would no longer be available for download on iOS devices. While customers who have already downloaded the app to their iOS device will not find their use of the app impacted, Owlet has said it won’t be able to make updates or changes to the app for iOS users.

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