FDA product code LXJ: Interactive Rehabilitation Exercise Devices
LXJ is the FDA product code for interactive rehabilitation exercise devices. It is a Class II device, regulated under 21 CFR 890.5360 and reviewed by the Physical Medicine panel. FDA has cleared 27 510(k) submissions under LXJ, from 21 different applicants. The average 510(k) review took 174 days (median 182).
Classification
| Field | Value |
|---|---|
| Device name | Interactive Rehabilitation Exercise Devices |
| Device class | Class II |
| Regulation | 21 CFR 890.5360 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for LXJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 154 |
| 2018 | 3 | 269 |
| 2019 | 3 | 197 |
Compare with all 510(k) review times · Search every LXJ clearance
Top LXJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reflexion Health, Inc. | 3 | 2019-10-10 |
| Motion Analysis Corp. | 3 | 1989-02-03 |
| Mindmaze SA | 2 | 2018-05-17 |
| Jintronix, Inc. | 2 | 2015-04-22 |
| Scientific Analytics, Inc. | 1 | 2019-03-07 |
16 more applicants have LXJ clearances. See the full list in Caduvo.
Most recent LXJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192474 | Reflexion Health, Inc. | VERA | 2019-10-10 | 30 |
| K182333 | Reflexion Health, Inc. | Vera | 2019-04-09 | 224 |
| K180880 | Scientific Analytics, Inc. | DARI Health | 2019-03-07 | 338 |
| K171547 | Qualisys AB | Qualisys Clinical System | 2018-08-02 | 433 |
| K173931 | Mindmaze SA | MindMotion(TM) GO | 2018-05-17 | 142 |
Recalls for LXJ devices
openFDA lists no recalls for product code LXJ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0422 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring with exercise, per session
- G0423 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring; without exercise, per session
Frequently asked questions
What is FDA product code LXJ?
LXJ is the FDA product code for interactive rehabilitation exercise devices. It is a Class II device, regulated under 21 CFR 890.5360 and reviewed by the Physical Medicine panel.
What device class is LXJ?
Class II, regulation 21 CFR 890.5360. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXJ?
Across 27 cleared submissions the average was 174 days from receipt to decision (median 182).
Which companies have the most LXJ clearances?
Reflexion Health, Inc. (3); Motion Analysis Corp. (3); Mindmaze SA (2); Jintronix, Inc. (2); Scientific Analytics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXJ
- Run a recall and safety report across every LXJ manufacturer
- Watch product code LXJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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