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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 K133225
Device Name E-FIT EF-1280 EMS MACHINE
Applicant
Fit-Pro Kft , Ltd.
144 Research Dr.
Hampton,  VA  23666
Applicant Contact RHONDA ALEXANDER, M.S., M.P.A.
Correspondent
Fit-Pro Kft , Ltd.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact RHONDA ALEXANDER, M.S., M.P.A.
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
GXY  
Date Received10/21/2013
Decision Date 10/24/2014
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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