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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 K220601
Device Name CoolTone
Zimmer MedizinSysteme GmbH
Junkersstrasse 9
Neu-Ulm,  DE 89231
Applicant Contact Julia Kredler
Quality and Regulatory Services
151 Glensondale Road
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number890.5850
Classification Product Code
Date Received03/02/2022
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No