DEVICE: MindMotion PRO (03760272650002)
Device Identifier (DI) Information
MindMotion PRO
MMPUS-01
In Commercial Distribution
MindMaze SA
MMPUS-01
In Commercial Distribution
MindMaze SA
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QKC | Interactive Rehabilitation Exercise Device, Prescription Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit |
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 78 and 102 KiloPascal |
Handling Environment Temperature: between 20 and 110 Degrees Fahrenheit |
Handling Environment Humidity: between 30 and 60 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 78 and 102 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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Width: 35 Inch |
Length: 35 Inch |
Height: 65 Inch |
Weight: 210 Pound |
Device Record Status
2e320882-86a8-46cb-adac-220ec6133ef3
February 09, 2022
4
August 01, 2017
February 09, 2022
4
August 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+41215520804
regulatory.affairs@mindmaze.ch
regulatory.affairs@mindmaze.ch