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MindMotion GO

by MindMaze SA

510(k) K173931

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173931↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173931 Date17 May 2018ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173931 decided 17 May 2018 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
MindMotion(TM) GO
510(k) Number
FDA product code
LXJ
Device class
Class II
Regulation
21 CFR Part 890.5360
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code LXJ (Interactive Rehabilitation Exercise Devices).

Other devices from MindMaze SA

  • MindMotionPRO

    Class II