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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 K240347
Device Name PTG-05
Applicant
Zimmer Medizinsysteme GmbH
Junkerstrasse 9
Neu-Ulm,  DE 89231
Applicant Contact Ute Killet
Correspondent
Qara Consulting, LLC
151 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number890.5850
Classification Product Code
NGX  
Date Received02/05/2024
Decision Date 07/21/2024
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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