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 Monito
| Device Type ID | 2730 |
| Device Name | Infant Positioner, Rx, Use In Highly Monitored Setting |
| 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 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) |
| CFR Regulation Number | 880.5680 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OUW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2730 |
| Device | Infant Positioner, Rx, Use In Highly Monitored Setting |
| Product Code | OUW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pediatric Position Holder. |
| CFR Regulation Number | 880.5680 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Molnlycke Health Care, Inc | II | Jan-26-2018 |