1. Home
  2. HubbleClub App
  3. Guardian+
  4. Can I consider Guardian+ a medical device?

Can I consider Guardian+ a medical device?

Guardian+ is not a medical device.

It is not intended to diagnose, treat, cure, or alleviate any disease or health condition, including, but not limited to, Sudden Infant Death Syndrome (SIDS). False positive or false negative readings about your baby’s patterns are a potential risk.

This product is only intended to assist you in tracking your baby’s well-being and is not intended to replace you as a caregiver. You are responsible for the health and well-being of your baby and should follow safe sleep, health, and care guidelines.

To obtain an optimal and safe user experience, please carefully read, understand, and follow all instructions and warnings before use. Also, read and follow recommendations from the American Academy of Pediatrics, including Safe Sleep guidelines found at www.healthychildren.org.

This product is not FDA approved.

Updated on December 6, 2022

Was this article helpful?

Related Articles

Need Support?
Can’t find the answer you’re looking for? Don’t worry we’re here to help!
Submit a Ticket