AccessGUDID - DEVICE: MindMotion PRO (03760272650002)

GUDID

Device Identifier (DI) Information

Brand Name: MindMotion PRO
Version or Model: MMPUS-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MindMaze SA

Primary DI Number: 03760272650002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486449510 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
QKC	Interactive Rehabilitation Exercise Device, Prescription Use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 2e320882-86a8-46cb-adac-220ec6133ef3
Public Version Date: February 09, 2022
Public Version Number: 4
DI Record Publish Date: August 01, 2017