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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
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