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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 K230261
Device Name Gnesis EMS Plus
Applicant
Creative Fitness Developments S.L.
Alfahuir, 40
Valencia,  ES 46020
Applicant Contact Jose Luis Delgado
Correspondent
Creative Fitness Developments S.L.
Alfahuir, 40
Valencia,  ES 46020
Correspondent Contact Jose Luis Delgado
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/31/2023
Decision Date 06/06/2023
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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