Definition: Device Used To Physically Restrain A Pediatric Patient For A Short Surgical Or Clinical Procedure Such As Circumcision. Not Intended For Prolonged Positioning.
| Device Type ID | 2754 |
| Device Name | Pediatric Position Holder |
| 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 Anatomi |
| Target Area | Pediatrics |
| Regulation Description | Pediatric Position Holder. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| 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 |
| CFR Regulation Number | 880.5680 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PRN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2754 |
| Device | Pediatric Position Holder |
| Product Code | PRN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pediatric Position Holder. |
| CFR Regulation Number | 880.5680 [🔎] |