FDA.reportPublic FDA data

NeuroXtherapeutics SA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135171463013517146NeuroXtherapeutics SA1N2026-01-01Chemin de Roseneck 5 Lausanne Vaud CH 1006

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03760272650002MindMotion PRO - MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.+41215520804regulatory.affairs@mindmaze.ch

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2073181106346497K173931MindMotion(TM) GOLXJ2018-05-17
2073181917847078K162748MindMotionPROLXJ2017-04-24
2073181797068650
2073181317775786
2073181517004284

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LXJ32018-05-17

GUDID#

MindMotion Toap Run - MindMotion ToapRun is a Software as Medical Device used with tracking solutions which tracks the patient's movements using the captured full-body motion parameters to drive gamified rehabilitation exercises in order to support the physical rehabilitation of adults in rehabilitation centers, and of adults at home. The software delivers high-dose, high-intensity training and includes rehabilitation exercises for gait and balance; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the healthcare professional. Exercise guidance and approval by the healthcare professional is required prior to and during us

NeuroXtherapeutics SA

2026-04-13

MindMotion GO Procedure Pack - "The MindMotion GO Procedure Pack is a combination of CE-marked and FDA-listed medical devices and compatible non-medical components packaged together and placed on the market by NeuroXtherapeutics SA in accordance with Article 22 of Regulation (EU) 2017/745. In the US, a procedure pack is commonly referred to as a “convenience kit”, defined as ""two or more different medical devices packaged together for the convenience of the user"" 21 CFR 801.3. Convenience kits are considered medical devices in their own right and must be listed under the primary intended use of the kit, using the most appropriate product code. The risk classification of the kit is determined by the highest risk component included. Therefore, MindMotion GO Procedure Pack is considered as a convenience kit in the US, but in all documentation it will be referred to it as 'Procedure Pack'.The Procedure Pack is assembled to enable the use of the medical devices MindMotion GO and Izar for their intended medical purposes. It provides healthcare professionals with the necessary components required for installation and operation of the devices in clinical settings or at a patient’s home under professional supervision.The Procedure Pack does not create a new medical intended purpose and does not modify the intended purpose, performance, or classification of the individual medical devices included therein."

NeuroXtherapeutics SA

2026-03-23

MindMotion GO Procedure Pack - The MindMotion GO Procedure Pack is a combination of CE-marked and FDA-listed medical devices and compatible non-medical components packaged together and placed on the market by NeuroXtherapeutics SA as convenience kit.The Procedure Pack is assembled to enable the use of the medical devices MindMotion GO and Izar for their intended medical purposes. It provides healthcare professionals with the necessary components required for installation and operation of the devices in clinical settings or at a patient’s home under professional supervision.The Procedure Pack does not create a new medical intended purpose and does not modify the intended purpose, performance, or classification of the individual medical devices included therein.

NeuroXtherapeutics SA

2026-03-16

Izar™ - Izar™ is intended to rehabilitate hand functions such as dexterous grasp, pinch, and grip, as well as wrist movements in adult patients with hand motor function impairment. This therapy device can be used as a controller for various activities allowing the patient to train within a therapy session and also alone to increase total therapy dose. The device can be used in all the environments the patient navigates; hospital, clinic, private practice, and at home.

NeuroXtherapeutics SA

2023-01-23

MindMotion™ GO - MindMotion GO is a medical device software used with motion tracking solutions to support the physical rehabilitation and motor recovery of adults. The software includes rehabilitation exercises for the hand, upper extremities, trunk, and lower extremities, as well as audio-visual feedback and graphic movement representations for patients. It also provides patient performance metrics for healthcare professionals. The device is intended for use under the direct or remote supervision of a healthcare professional, either in clinical settings or at a patient's home.

NeuroXtherapeutics SA

2018-05-28