They didn't follow the laws that govern medical devices & were marketing it with claims they didn't have the support for: https://www.fda.gov/inspections-compliance-enforcement-and-c...

"Since 2016, the FDA has corresponded with Owlet that the Owlet Smart Sock meets the definition of a device under the FD&C Act and does not fall under the compliance policy for low-risk products that promote a healthy lifestyle (General Wellness guidance)."

Yikes it does seem that they were playing games with their marketing and stringing the FDA along.