| Device Type ID | 2555 |
| Device Name | Protector, Skin Pressure |
| Regulation Description | Skin Pressure Protectors. |
| 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 | 880.6450 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FMP |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2555 |
| Device | Protector, Skin Pressure |
| Product Code | FMP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Skin Pressure Protectors. |
| CFR Regulation Number | 880.6450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INVICTUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 7 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Detachment Of Device Component | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Jan-06-2016 |
| 2 | Childrens Medical Ventures | I | Aug-20-2014 |
| 3 | Philips Medical Systems, Inc. | I | Dec-16-2014 |