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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 K132179
Device Name ARASYS
Applicant
ION GENIUS INC
1833 KALAKAUA AVE.
HONOLULU,  HI  96801
Applicant Contact XANYA SOFRA-WEISS, PH.D
Correspondent
ION GENIUS INC
1833 KALAKAUA AVE.
HONOLULU,  HI  96801
Correspondent Contact XANYA SOFRA-WEISS, PH.D
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/15/2013
Decision Date 04/28/2014
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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