QTG · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5690
Classification
FDA Product Code
QTG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5690
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).