K173931 is an FDA 510(k) clearance for the MindMotion(TM) GO. This device is classified as a Interactive Rehabilitation Exercise Devices (Class II - Special Controls, product code LXJ).
Submitted by Mindmaze SA (Lausanne, CH). The FDA issued a Cleared decision on May 17, 2018, 142 days after receiving the submission on December 26, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K173931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2017 |
| Decision Date | May 17, 2018 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | LXJ — Interactive Rehabilitation Exercise Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |