Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-