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U.S. Department of Health and Human Services

Product Classification

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Device holder, infant position
Regulation Description Pediatric position holder.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRP
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? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons