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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 K182963
Device Name emFieldPro
Applicant
Zimmer MedizinSysteme GmbH
Junkersstrasse 9
Neu-Ulm,  DE 89231
Applicant Contact Ute Hauss
Correspondent
Quality and Regulatory Services
22 Nichols Street #2
Salem,  MA  01970
Correspondent Contact Scott Blood
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/25/2018
Decision Date 06/21/2019
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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