MindMotion GO Procedure Pack

GUDID 03760272650880

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

Virtual-display rehabilitation system, non-supportive, home-use

• Primary Device ID: 03760272650880
• NIH Device Record Key: 6132fd54-d0be-47bb-8ff0-6c58b7a3d058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MindMotion GO Procedure Pack
• Version Model Number: MMG-02-PC3-AAA-02-US
• Company DUNS: 486843613
• Company Name: NeuroXtherapeutics SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41215520801
• Email: pomme.boissier@neurodtx.ai
• Phone: +41215520801
• Email: pomme.boissier@neurodtx.ai
• Phone: +41215520801
• Email: pomme.boissier@neurodtx.ai
• Phone: +41215520801
• Email: pomme.boissier@neurodtx.ai
• Phone: +41215520801
• Email: pomme.boissier@neurodtx.ai
• Phone: +41215520801
• Email: pomme.boissier@neurodtx.ai

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760272650880 [Primary]

FDA Product Code

• QKC: Interactive Rehabilitation Exercise Device, Prescription Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [MindMotion GO Procedure Pack]

• 03760272650774: The MindMotion GO Procedure Pack is a combination of CE-marked and FDA-listed medical devices an
• 03760272650880: The MindMotion GO Procedure Pack is a combination of CE-marked and FDA-listed medical devices an