• 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 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
-
-