| Device Type ID | 5119 |
| Device Name | Table, Powered |
| Regulation Description | Powered Table. |
| 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) Exempt |
| CFR Regulation Number | 890.3760 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | INQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5119 |
| Device | Table, Powered |
| Product Code | INQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Table. |
| CFR Regulation Number | 890.3760 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Use Of Device Problem | 1 |
Solder Joint Fracture | 1 |
Device Operational Issue | 1 |
Unintended Movement | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ARJOHUNTLEIGH POLSKA Sp. Z.o.o. | II | Oct-11-2018 |