| Device Type ID | 5219 |
| Device Name | System, Optical Position/movement Recording |
| Regulation Description | Measuring Exercise Equipment. |
| 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 | 890.5360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LXJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5219 |
| Device | System, Optical Position/movement Recording |
| Product Code | LXJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Measuring Exercise Equipment. |
| CFR Regulation Number | 890.5360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BTS S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BTS SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JINTRONIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MINDMAZE SA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUALISYS AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 1 |
| Total Device Problems | 1 |