| Device Type ID | 5248 |
| Device Name | Manipulator, Plunger-like Joint |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LXM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5248 |
| Device | Manipulator, Plunger-like Joint |
| Product Code | LXM |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINAL ACOUSTICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |