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U.S. Department of Health and Human Services

Product Classification

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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).
Physical State Bassinet with mattress that includes tightly woven fabric components.
Technical Method Bassinet and tightly woven fabric components that hold the infant in a supine position during sleep.
Target Area The whole body.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQTG
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5690
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible