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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
Predetermined Change
Control Plan Authorized		 No
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