Happiest Baby is proud to announce that SNOO is the first—and only— medical device to receive De Novo approval from the Food and Drug Administration (FDA) for its ability to keep sleeping babies safely on their backs. Here are the details about SNOO’s FDA Clearance.
Indications for Use
The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at a lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.
Note Regarding Indications for Use
The American Academy of Pediatrics states that babies should be placed on their “[b]ack to sleep for every sleep. To reduce the risk of sleep-related death, it is recommended that infants be placed for sleep in a supine (back) position for every sleep by every caregiver until the child reaches 1 year of age. Side sleeping is not safe and is not advised.”1 The National Institute of Child Health and Human Development also states that caregivers should “place all babies—including those born preterm and those with reflux—on their backs to sleep until they are 1 year old.”2
The SNOO is demonstrated to facilitate a supine position during sleep; however, the SNOO has not directly demonstrated a reduction in the incidence of SIDS/SUID.
This device is indicated for use in infants from birth to 6 months of age, until babies can roll over consistently. “Roll over consistently” means the baby has demonstrated - on multiple occasions - the ability to roll from stomach to back during sleep. Parents should be advised that prone (stomach) sleeping is never safe when a baby is swaddled or in the presence of soft bedding or toys in the sleep environment.
Contraindications
DO NOT USE this product if the infant can push up on hands and knees, or has reached 6 months of age, whichever comes first.
DO NOT USE this product if the infant has any condition that would prevent placement in the supine position.
Note: If your baby has a medical condition and you have questions about whether the back sleeping position and/or SNOO are appropriate, please contact your child’s health care provider prior to use.
Warnings
FAILURE TO FOLLOW THESE WARNINGS AND INSTRUCTIONS COULD RESULT IN SERIOUS INJURY OR DEATH. READALL INSTRUCTIONS BEFORE ASSEMBLY AND USE OF THE PRODUCT. ADULT ASSEMBLY REQUIRED. DO NOT USE THIS DEVICE IF IT IS DAMAGED OR BROKEN.
THE SNOO IS DEMONSTRATED TO FACILITATE A SUPINE POSITION DURING SLEEP; HOWEVER, THE SNOO HAS NOT DIRECTLY DEMONSTRATED A REDUCTION IN THE INCIDENCE OF SIDS/SUID.
THIS DEVICE IS ONLY INDICATED FOR USE WITH INFANTS WHO CANNOT CONSISTENTLY ROLL OVER.
Prevent Fall Hazards
- To help prevent falls, DO NOT USE this product if the infant can push up on hands and knees, or has reached 6 months of age, whichever comes first.
- Maximum weight: 25 lb (11.3 kg)
1 Moon, R. Y., Carlin, R. F., Hand, I. (2022, June 21). Sleep-related infant deaths: Updated 2022 recommendations for reducing infant deaths in the sleep environment. American Academy of Pediatrics. Pediatrics (2022) 150(1)
2 https://safetosleep.nichd.nih.gov/
 |
 |