Dream with Health Notifications: Who Should Use the Dream Sock

Before First Use

Do the following before using Dream Sock for the first time:

  • Read the entire user manual
  • Understand the warnings and precautions
  • Set up the Owlet Dream App
  • Fully charge the Sensor

Who Should Use Dream Sock? 

Dream Sock is indicated for:

  • In-home monitoring
  • Healthy babies 1-18 months of age and 6-30 lbs
  • Use during baby’s sleep

Dream Sock is an over-the-counter medical device and is not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition. 

Who Should NOT Use Dream Sock? 

Dream Sock is NOT indicated for:

  • Babies and children with ongoing health conditions
  • Infants weighing less than 6 pounds
  • Children weighing more than 30 pounds
  • Use as a substitute for Caregiver supervision
  • Use as a substitute for safe sleep practices

Intended Use 

The Owlet Dream Sock is intended to assist caregivers in tracking their child’s well-being by monitoring sleep patterns, quality, and duration of sleep. When enabled (in-home use on healthy infants only), the Owlet Dream Sock displays pulse rate (PR) and oxygen saturation (SpO2) values and provides a notification in the rare instance that the values move outside of a preset zone.

Indications for Use

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 the 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.