LXJClass II
Interactive Rehabilitation Exercise Devices
21 CFR 890.5360 / Physical Medicine
LXJ is the FDA product code for Interactive Rehabilitation Exercise Devices, a class II device type, regulated under 21 CFR 890.5360. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- LXJ
- Device name
- Interactive Rehabilitation Exercise Devices
- Regulation
- 21 CFR 890.5360
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 27
- Ingested recalls
- 0
Clearances, product code LXJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1991 | 1 |
| 1993 | 2 |
| 1995 | 1 |
| 1998 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 3 |
Applicants with the most clearances
Product code LXJ| Applicant | Clearances |
|---|---|
| Motion Analysis Corp. | 3 |
| Reflexion Health, Inc. | 3 |
| Jintronix Inc. | 2 |
| Mindmaze SA | 2 |
| Barron Associates, Inc. | 1 |
| Biogaming, Ltd. | 1 |
| Bts S.p.A. | 1 |
| Charnwood Dynamics, Ltd. | 1 |
| Emovi | 1 |
| Epm Information Systems, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
