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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 K182794
Device Name BionicGym Powered Muscle Stimulator
Applicant
Medical Currents Ltd
8 Cuffe Lane
Dublin 2,  IE D02W840
Applicant Contact Louis Crowe
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/01/2018
Decision Date 07/18/2019
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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