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Owlet Gets FDA Warning Letter for Unapproved ‘Smart Socks’ for Infants

October 12, 2021

A Utah company has received an FDA warning letter for marketing its “Smart Socks” for infants as medical devices without FDA approval or clearance.

The company disclosed the warning letter in an announcement to investors. As cited by Owlet, the FDA said the company was promoting the Smart Socks as being able to measure blood oxygen saturation and pulse rate.

The unapproved medical purpose was diagnosing desaturation and bradycardia, and setting off an alarm to notify caregivers.

In a move that is unlikely to resolve the matter, the company has added a disclaimer on its website stating that the Smart Sock “is an information-gathering product for use with healthy babies only. It is not a medical device.”

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