NeuroXtherapeutics SA

FDA Registration(s)#

GUDID Contact Samples#

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

• mindmaze.ch

Registered Device Listings#

Product Codes Associated With Registrations#

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 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.

  NeuroXtherapeutics SA

  2017-08-01

• 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

• MindPod Dolphin - MindPod Dolphin is a medical device software that delivers high-dose, high-intensity training to support the physical and cognitive rehabilitation of adults in healthcare facilities. The software, used with a tracking solution, provides a digital therapeutic environment that promotes 3D exploratory movements of the arms and upper limbs using a combination of animated gaming, real-time feedback, and movement tracking.

  NeuroXtherapeutics SA

  2019-06-27