The following data is part of a premarket notification filed by Mindmaze Sa with the FDA for Mindmotionpro.
| Device ID | K162748 |
| 510k Number | K162748 |
| Device Name: | MindMotionPRO |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | MindMaze SA Chemin De Roseneck 5 Lausanne, CH Ch-1006 |
| Contact | Sylvain Bourriquet |
| Correspondent | John Beasley MEDTECH REVIEW, LLC 257 GARNET GARDEN STREET Henderson, NV 89015 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-04-24 |