| Device Type ID | 2560 |
| Device Name | Cover, Mattress (medical Purposes) |
| Regulation Description | Mattress Cover For Medical Purposes. |
| 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 | 880.6190 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FMW |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2560 |
| Device | Cover, Mattress (medical Purposes) |
| Product Code | FMW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mattress Cover For Medical Purposes. |
| CFR Regulation Number | 880.6190 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PRECISION FABRICS GROUP INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION FABRICS GROUP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Rupture | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Primus Medical LLC | II | Sep-09-2014 |