DeviceClearance

Product code OUW— General Hospital

Nurture Rest

Classification name
Infant Positioner, Rx, Use In Highly Monitored Setting
Device class
Class 1
Regulation
21 CFR 880.5680
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring.”

— U.S. Food and Drug Administration, device classification record for product code OUW under 21 CFR 880.5680, via openFDA

Market context for product code OUW

FDA has cleared 1 device under product code OUW, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OUW

Recent clearances under product code OUW

Data sourced from openFDA. This site is unofficial and independent of the FDA.