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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 K181419
Device Name FLIX-EMS
Applicant
Casgarum Investment, S.L.
Calle Real, 17 Bº E
Illescas,  ES 45200
Applicant Contact Rafael Castillo
Correspondent
Casgarum Investment, S.L.
Calle Real, 17 Bº E
Illescas,  ES 45200
Correspondent Contact Rafael Castillo
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/31/2018
Decision Date 05/14/2019
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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