Owlet Stops Selling Their Baby-Monitoring Smart Sock After FDA Warning – Here’s What Parents Need to Know
This baby registry must-have item is no longer being sold and parents have lots of questions.
Wearable devices that monitor your baby while they sleep have become a new parent must-have item in recent years. They can offer new parents peace of mind and help them relax during those early days of parenthood. Recently Owlet, the brand behind the Smart Sock, has stopped making their popular product after a warning from the Food and Drug Administration (FDA). This decision has left many parents wondering what happened and whether it is safe to continue using their Smart Sock.
Here’s everything you need to know about the company’s decision and what to do if you have an Owlet Smart Sock.
The FDA sent a letter to Owlet in October stating that the Smart Sock was being sold without the proper approval from the agency. The Smart Sock would wrap around the baby’s foot and monitor their heart rate and oxygen levels while the baby slept. If those levels dropped, parents were alerted via an app on their phone. Since the socks notify parents about potentially dangerous drops in heart rate and blood oxygen, the agency said Smart Socks needed to be classified as medical devices and to be approved through the proper channels.
In response to the letter, Owlet made the decision to stop selling the Smart Sock. However, it’s important to note that there were no safety concerns mentioned in the letter from the FDA and the company says that no parents have reported injuries from the Owlet. The company reports that over one million Smart Socks have been sold in the United States and that parents should feel comfortable continuing to use the devices.
In their response, Owlet said they would be working with the FDA to find a solution for future products. "After six years on the market, four versions launched and over 1 million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered. 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."
While the company is no longer selling the product on their website and it’s getting harder to find the Smart Sock through other retailers like Amazon or Buy Buy Baby, the company did state in their response letter that they "plan to work toward the submission of a device application to FDA."
So what about parents who were hoping to purchase the Smart Sock? The company announced plans to sell an updated version in January. Stating on their website, "We plan to offer a new sleep monitoring solution in the U.S., which will be available in January 2022. Additionally, we plan to continue to support our current customers and will notify them of any updates to the Smart Sock products that have already been distributed."
If you are creating a new baby registry, Owlet’s new monitoring device will be available soon and for current users, you can feel safe continuing to use the product while your little one sleeps.
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