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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 K131094
Device Name VIMOVE
Applicant
Dorsa VI Pty., Ltd.
1914 J.N. Pease Place
Chalotte,  NC  28262
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Dorsa VI Pty., Ltd.
1914 J.N. Pease Place
Chalotte,  NC  28262
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
HCC   KQX  
Date Received04/18/2013
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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