Owlet Baby Care, Inc.

Warning LetterClosed

Mr. Kurt Workman Chief Executive Officer Owlet Baby Care, Inc. 2500 Executive PKWY Suite 500 Lehi , UT 84043 United States kworkman@owletcare.comIssued Oct 5, 2021Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateOct 5, 2021

Product TypeMedical Devices

StatusClosed

Closeout LetterJun 28, 2024

Letter Details

Firm: Owlet Baby Care, Inc.
Location: Mr. Kurt Workman Chief Executive Officer Owlet Baby Care, Inc. 2500 Executive PKWY Suite 500 Lehi , UT 84043 United States kworkman@owletcare.com
FEI Number: N/A
Country: United States
Issue Date: October 05, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: June 28, 2024

Summary

Owlet Baby Care, Inc. was warned for marketing the Owlet Smart Sock Family (versions 1, 2, 3, Smart Sock Plus, and co-packaged products) without required FDA marketing clearance or approval. The devices, which measure blood oxygen saturation and pulse rate to diagnose desaturation and bradycardia, were classified as adulterated under federal law because the company lacked either an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE). The FDA documented that the company was actively selling these products on multiple commercial websites, including Amazon, without any valid marketing authorization as of July 2021.

Owlet Baby Care, Inc. FDA Warning Letter, October 5, 2021