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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K062792
Device Name ERCHONIA IOTO_240
Applicant
Erchonia Medical, Inc.
13 Red Fox Ln.
Littleton,  CO  80127
Applicant Contact KEVIN WALLS,RAC
Correspondent
Erchonia Medical, Inc.
13 Red Fox Ln.
Littleton,  CO  80127
Correspondent Contact KEVIN WALLS,RAC
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received09/18/2006
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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