FDA Issues Warning Letter to Baby Product Company Owlet

Owlet received a letter from the Food and Drug Administration regarding its Smart Sock product.  The warning letter states that since the product is considered a medical device requiring pre-market clearance or approval from the FDA, which it has not obtained, it is therefore in violation of the Federal, Food, Drug, and Cosmetic Act.  The letter advises Owlet to stop the commercial distribution of the Smart Sock for the purpose of measuring blood oxygen saturation and pulse.  The Smart Sock product tracks a baby’s heart rate, sleep trends and oxygen levels.

Despite the FDA warning letter, Owlet advises its product is still safe for its intended use.  However, the company has not obtained the required FDA clearance or approval.  

If you have purchased Smart Sock for its intended use, to track a baby’s heart rate, sleep trends and oxygen levels, the baby may be at risk.  Please contact us immediately to discuss your legal options.  The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully prosecuted numerous consumer protection actions and we look forward to discussing this matter with you.