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What this means for every baby and every caregiver

  • This new clearance will allow Dream Sock users to track their infant’s Live Health Readings, including pulse rate and oxygen saturation level.
  • The clearance includes Owlet’s new Health Notifications, which will alert parents with lights and alarm sounds when their child’s health readings fall outside of preset ranges.
  • Achieving De Novo clearance, the first of its kind, means the Owlet Dream Sock was clinically and technically tested and proven to be as accurate as medical-grade baby monitoring technology.
  • Available for healthy infants 1-18 months, 6-30 lbs.
  • These new FDA-cleared features will begin rolling out to both existing and new Dream Sock users at the end of this year, in the U.S. only.
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FAQs

When will the FDA-cleared Dream Sock features be available?
If I currently have a Dream Sock, will I get Live Health Readings and Health Notifications?
How do I get access to the new FDA-cleared features?
Do I need a prescription for Dream Sock?
How much will it be? Is there a fee to “upgrade”?
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Indications for Use statement:

The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.

The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant.

The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.The Dream Sock is not intended for use with infants previously diagnosed with cardiovascular or respiratory disease or conditions.