Owlet Baby CareAs a seller of intelligent monitoring socks for nearly six years, we have recently receivedUS Food and Drug AdministrationThe FDA issued a notice to Owlet Baby Care in October stating that the product was sold as a medical device without federal agency approval.
According to the company's website version targeting consumers in another country,Owl Smart Socks is described as being able to track a child's heart rate, oxygen levels, and sleep trends, which can be read in real-time through the company's Owl application.
According to the website, these socks are aimed atSales for children under 5 years old. The product is no longer available on American consumer websites. In the warning letter, the FDA claimed that Owlet violated the Federal Food, Drug, and Cosmetic Act,alsoSell the product in the United States without marketing license or approval.
according tocorrelationAct,This classproductbelong toDevices, as they are designed to diagnose diseases or other conditions, or to cure, alleviate, treat or prevent diseases, or to affect the structure or any function of the body,FDAIn the warning letterWrite.
Image fromOwlet official website
The FDA stated that it has been notifying the company since 2016,Claim that this device product does not meet the requirementsCompliance policies for low-risk products that promote healthy lifestyles. At that time, the company also claimed that the product had been evaluated in third-party research and proved to be reliableproductsecurity.
In addition, the company's website also explains thatOwlet ProductsNotMedical equipment.
OwlIn itsThe disclaimer states that,They are not intended for use as medical devices or as alternative medical devices. However,The FDA requested in the warning letter that the companyshouldStop any activities that lead to adulteration,Including itsAll versions of products and co branded products.
Due to this letter and theAccording to the FDA's plan to submit a device application, Owlet will cease selling the product.However,The companyWe plan to provide a new sleep monitoring solution, which is expected to be launched soon.
The companyRegarding this matterreiterateroad,These actions onlyWill have an impact on itUS clientsproduceAffected, other countries or regions are not affected by this.
It is understood that they have launched four versions and provided services exceeding1 million infants. The company will invest more energy in developing new products.