| Device Type ID | 2585 |
| Device Name | Stretcher, Hand-carried |
| Regulation Description | Hand-carried Stretcher. |
| 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 | 880.6900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FPP |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2585 |
| Device | Stretcher, Hand-carried |
| Product Code | FPP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hand-carried Stretcher. |
| CFR Regulation Number | 880.6900 [🔎] |
| Device Problems | |
|---|---|
Break | 7 |
Detachment Of Device Component | 5 |
Detachment Of Device Or Device Component | 4 |
Device Subassembly | 3 |
Handpiece | 3 |
Bent | 2 |
Component Missing | 2 |
Unintended Movement | 2 |
Device Slipped | 2 |
Naturally Worn | 1 |
Insufficient Information | 1 |
Belt | 1 |
Positioning Problem | 1 |
Difficult To Fold Or Unfold | 1 |
Structural Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Latch | 1 |
Difficult Or Delayed Positioning | 1 |
Unintended System Motion | 1 |
Device Operates Differently Than Expected | 1 |
Device Fell | 1 |
Lock | 1 |
Device Inoperable | 1 |
| Total Device Problems | 44 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Winco Mfg., LLC | II | Oct-10-2016 |