• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device infant positioner, rx, use in highly monitored setting
Regulation Description Pediatric position holder.
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.
Physical State DEVICE MAY BE WEDGE SHAPED TO MAINTAIN THE INFANT AT A 30 DEGREE ANGLE. MAY ALSO HAVE A COMPONENT THAT IS USED TO HELP MAINTAIN THE INFANT ON THE POSITIONER SUCH AS A BINDER.
Technical Method MAINTAINS INFANT IN A DESIRED POSITION.
Target Area WHOLE BODY.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOUW
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5680
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-