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510(k) Data Aggregation
K Number
K173931Device Name
MindMotion(TM) GO
Manufacturer
MindMaze SA
Date Cleared
2018-05-17
(142 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
MindMaze SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 exercise guidance, and approval by the medical professional is required prior to use.
Device Description
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K Number
K162748Device Name
MindMotionPRO
Manufacturer
MindMaze SA
Date Cleared
2017-04-24
(206 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
MindMaze SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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