| Device Type ID | 2826 |
| Device Name | Table, Examination, Medical, Powered |
| Regulation Description | Operating Tables And Accessories And Operating Chairs And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.4960 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2826 |
| Device | Table, Examination, Medical, Powered |
| Product Code | LGX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Operating Tables And Accessories And Operating Chairs And Accessories. |
| CFR Regulation Number | 878.4960 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 3 |
Device Issue | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Unintended System Motion | 1 |
Overheating Of Device | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Brewer Company, LLC | II | Jul-24-2018 |
| 2 | Medical Positioning Inc | II | Aug-13-2014 |