Cleared Traditional

ERCHONIA IOTO_240

K062792 · Erchonia Medical, Inc. · Physical Medicine
Mar 2007
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K062792 is an FDA 510(k) clearance for the ERCHONIA IOTO_240, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Erchonia Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on March 1, 2007, 164 days after receiving the submission on September 18, 2006. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K062792 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2006
Decision Date March 01, 2007
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code EGJ — Device, Iontophoresis, Other Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525

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