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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 K162748
Device Name MindMotionPRO
Applicant
MindMaze SA
Chemin de Roseneck 5
Lausanne,  CH CH-1006
Applicant Contact SYLVAIN BOURRIQUET
Correspondent
MEDTECH REVIEW, LLC
257 GARNET GARDEN STREET
HENDERSON,  NV  89015
Correspondent Contact JOHN BEASLEY
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received09/30/2016
Decision Date 04/24/2017
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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