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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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