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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infant supine sleep system
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).
Product CodeQTG
Regulation Number 880.5690
Device Class 2


Premarket Reviews
ManufacturerDecision
HAPPIEST BABY, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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