LOS ANGELES - Owlet has stopped selling its Smart Sock, the company’s flagship product that wraps around a baby’s foot to monitor their heart rate and oxygen levels, after it received a warning letter from the U.S.
Food and Drug Administration. The Los Angeles-based company said the FDA "did not identify any safety concerns about the Smart Sock," but rather the agency asserted that the technology should be "classified as a medical device in the U.S.
because of the heart rate and oxygen notifications."The agency states in the letter that Owlet has sold the product without "marketing approval, clearance, or authorization from the FDA."Owlet said it plans to submit a device application to the FDA soon as a result of the letter.