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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 DRIVE
HAMPTON,  VA  23666
Applicant Contact RHONDA ALEXANDER, M.S., M.P.A.
Correspondent
FIT-PRO KFT LTD.
144 RESEARCH DRIVE
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
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