MindMotion™ GO

Basic Information

• Brand Name: MindMotion™ GO
• Primary DI: 03760272650019
• Version / Model: MMG-01
• Company Name: MindMaze SA
• Labeler DUNS: 486449510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-28
• Public Version: 3
• Public Version Date: 2022-02-09
• Public Version Status: Update
• Public Device Record Key: ca78fc1c-e773-4de9-af1d-dde3871f62b9

Device Description

MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
60925	Virtual-display rehabilitation system, non-supportive, clinical	An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/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., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760272650019	GS1

Customer Contacts

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