# Infant Supine Sleep System
> **Product code: 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).

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QTG)
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