MindMotion GO Procedure Pack

Basic Information

• Brand Name: MindMotion GO Procedure Pack
• Primary DI: 03760272650880
• Version / Model: MMG-02-PC3-AAA-02-US
• Company Name: NeuroXtherapeutics SA
• Labeler DUNS: 486843613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-23
• Public Version: 1
• Public Version Date: 2026-03-31
• Public Version Status: New
• Public Device Record Key: 6132fd54-d0be-47bb-8ff0-6c58b7a3d058

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60926	Virtual-display rehabilitation system, non-supportive, home-use	An assembly of devices intended to be used both in a home and clinical setting and to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back, trunk, and/or limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., patient-worn infrared (IR) glove, motion tracking heel pad or camera, software] that communicate to provide a virtual-display interface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760272650880	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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