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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
MindMaze SA
Chemin de Roseneck 5
Lausanne,  CH CH-1006
Applicant Contact Sylvian Bourriquet
MindMaze SA
Chemin de Roseneck 5
Lausanne,  CH CH-1006
Correspondent Contact Sylvian Bourriquet
Regulation Number890.5360
Classification Product Code
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