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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 K253408
Device Name CoolTone
Applicant
Zimmer Medizinsysteme GmbH
Junkersstrasse 9
Neu-Elm,  DE 89231
Applicant Contact Ute Killet
Correspondent
Zimmer Medizinsysteme GmbH
151 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
IPF  
Date Received09/30/2025
Decision Date 01/16/2026
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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