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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K182519
Device Name Miha Bodytec II
Applicant
Miha Bodytec Gmbh
Siemensstr. 1
Gersthofen,  DE 86368
Applicant Contact Juergen Decker
Correspondent
IUVO Consulting, LLC
P.O. Box 56483
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/13/2018
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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