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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 K151834
Device Name BEMER Classic Set, BEMER Pro-Set
Applicant
Bemer Int AG
Austrasse 15
Triesen,  LI 9495
Applicant Contact Sven Bieler
Correspondent
Biomaterialize
P.O. Box 50
Tecumseh,  MI  49286
Correspondent Contact Sven Bieler
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/06/2015
Decision Date 02/22/2017
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
Recalls CDRH Recalls
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