"The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classif

"The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications,”" Their "its not an issue" response is scary -- if I'm reading the FDA letter correctly, its not just about marketing, they never proved the safety or critical features, and the FDA has been after them since 2016. Part of premarket approval is determining device class and appropriate regulations. Of course they have no immediate safety concerns if the product was never even submitted for approval! How could they know? Tickle-me-elmo probably has no immediate safety issues till you compare it to a medical device.