DEVICE: MindMotion PRO (03760272650002)

Device Identifier (DI) Information

MindMotion PRO
MMPUS-01
In Commercial Distribution

MindMaze SA
03760272650002
GS1

1
486449510 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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No
No

GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
QKC Interactive Rehabilitation Exercise Device, Prescription Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
Width: 35 Inch
Length: 35 Inch
Height: 65 Inch
Weight: 210 Pound
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Device Record Status

2e320882-86a8-46cb-adac-220ec6133ef3
February 09, 2022
4
August 01, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+41215520804
regulatory.affairs@mindmaze.ch
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