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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 K201975
Device Name miha bodytec II
Applicant
Miha Bodytec Gmbh
Siemensstr. 1
Gersthofen,  DE 86368
Applicant Contact Felix Schweigert
Correspondent
Miha Bodytec Gmbh
Siemensstr. 1
Gersthofen,  DE 86368
Correspondent Contact Felix Schweigert
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
IPF  
Date Received07/16/2020
Decision Date 03/11/2021
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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