| Device Type ID | 2556 |
| Device Name | Restraint, Protective |
| Regulation Description | Protective Restraint. |
| 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 | 880.6760 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FMQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2556 |
| Device | Restraint, Protective |
| Product Code | FMQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Protective Restraint. |
| CFR Regulation Number | 880.6760 [🔎] |
| Device Problems | |
|---|---|
Break | 20 |
Device Contaminated During Manufacture Or Shipping | 11 |
Torn Material | 9 |
Material Separation | 7 |
Device Operates Differently Than Expected | 6 |
Detachment Of Device Component | 5 |
Mechanical Problem | 5 |
Insufficient Information | 4 |
Material Rupture | 4 |
Material Integrity Problem | 4 |
Defective Component | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Difficult To Open Or Close | 2 |
Detachment Of Device Or Device Component | 2 |
Device Slipped | 2 |
Stretched | 1 |
Defective Device | 1 |
Device Difficult To Setup Or Prepare | 1 |
Use Of Device Problem | 1 |
Escape | 1 |
| Total Device Problems | 91 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DeRoyal Industries Inc | II | Mar-14-2014 |
| 2 | Med Tec Inc | II | Sep-14-2015 |
| 3 | Med Tec Inc | II | Jan-15-2015 |