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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
510(k) Number K203488
Device Name emField
Applicant
Zimmer Medizinsysteme GmbH
Junkersstrasse 9
Neu-Elm,  DE 89231
Applicant Contact Ute Hauss
Correspondent
Quality and Regulatory Services
151 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/27/2020
Decision Date 02/19/2021
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
Predetermined Change
Control Plan Authorized		 No
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