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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 K123158
Device Name ION MAGNUM GENIUS
Applicant
ION GENIUS INC
7192 KALANIANAOLE HWY
#D-204A
HONOLULU,  HI  96821
Applicant Contact XANYA SOFRA-WEISS
Correspondent
ION GENIUS INC
7192 KALANIANAOLE HWY
#D-204A
HONOLULU,  HI  96821
Correspondent Contact XANYA SOFRA-WEISS
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/09/2012
Decision Date 06/21/2013
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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