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U.S. Department of Health and Human Services

Product Classification

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Device pediatric position holder
Regulation Description Pediatric position holder.
Definition Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.
Physical State Made of non-permeable and non-porous material
Technical Method The pediatric position holder is a device made of non-permeable and non-porous material and molded with smooth edges for single patient use or multi-patient reuse. Holders that use disposable straps are used to hold an infant or a child in an anatomically correct position during short medical procedures such as circumcision. The holder is used only under constant supervision of a medical professional in a health care facility and is for prescription use only.
Target Area Pediatrics
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePRN
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) Exempt
Regulation Number 880.5680
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible