| Device Type ID | 5114 |
| Device Name | Stretcher, Wheeled, Powered |
| Regulation Description | Powered Wheeled Stretcher. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.3690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | INK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5114 |
| Device | Stretcher, Wheeled, Powered |
| Product Code | INK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Wheeled Stretcher. |
| CFR Regulation Number | 890.3690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unintended Movement | 15 |
Mechanical Jam | 14 |
Intermittent Loss Of Power | 13 |
Mechanical Problem | 12 |
Electrical /Electronic Property Problem | 8 |
Device Stops Intermittently | 5 |
Grounding Malfunction | 5 |
Peeled / Delaminated | 2 |
Device Fell | 2 |
Unintended System Motion | 1 |
Physical Resistance / Sticking | 1 |
Insufficient Information | 1 |
| Total Device Problems | 79 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Medical Division Of Stryker Corporation | II | Mar-17-2016 |