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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K173931
Device Name MindMotion(TM) GO
Applicant
MindMaze SA
Chemin de Roseneck 5
Lausanne,  CH CH-1006
Applicant Contact Sylvian Bourriquet
Correspondent
MindMaze SA
Chemin de Roseneck 5
Lausanne,  CH CH-1006
Correspondent Contact Sylvian Bourriquet
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received12/26/2017
Decision Date 05/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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