MindMotion GO
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by MindMaze SA
Identifiers
- 510(k) Number
- K173931 FDA 510(k)
- FDA Product Code
- LXJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5360 FDA 510(k)
- Regulation Number
- 890.5360 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MindMotion GO is an Interactive Rehabilitation Exercise Device, designed to facilitate physical therapy and motor rehabilitation through interactive, gamified exercises. It integrates motion tracking and virtual reality to engage patients in structured, repetitive movements aimed at improving mobility, strength, and coordination in physical medicine settings.
Supplied as a reusable system, the device operates in clinical or home-based rehabilitation environments and requires no sterilisation. It is classified as Class II under FDA regulations and complies with the Medical Device Directive (MDD). Multiple FEI numbers (3020018; 3005998761; etc.) and a product code (LXJ) identify its regulatory submissions, with no indication of single-use constraints or MRI compatibility restrictions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173931 | Class II | Active |
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Manufacturer
- Manufacturer
- MindMaze SA
Sources (2)
- FDA 510(k) K173931 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026