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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K142494
FOIA Releasable 510(k) K142494
Device Name ViMove
Applicant
dorsaVi Ltd.
Level 1, 120 Jolimont Road
East Melbourne,  AU 3002
Applicant Contact Dan Ronchi
Correspondent
MJ RAC
1208-12 Rockford Rd.
Toronto,  CA M2R 3A2
Correspondent Contact Bosmat Friedman
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
HCC   KQX  
Date Received09/05/2014
Decision Date 05/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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