Cleared Traditional

K063465 - CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE

K063465 is an FDA 510(k) clearance for CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE, manufactured by Iomed, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K063465 · Iomed, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
104d
Days
Class 2
Risk

K063465 is an FDA 510(k) clearance for the CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 28, 2007 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K063465

510(k) Number K063465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2006
Decision Date February 28, 2007
Days to Decision 104 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 116d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 67
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K063465.
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007
MESODERM
K061849 · Aa Advanced Technology, Inc. · Apr 2007
ERCHONIA IOTO_240
K062792 · Erchonia Medical, Inc. · Mar 2007
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
K061522 · Activatek, Inc. · Aug 2006
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814 · Dynatronics Corp. · Jun 2006
COMFORT/IO IONTOPHORESIS ELECTRODES
K060579 · Pepin Mfg., Inc. · Apr 2006
K063465 · CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
Download PDF FDA Summary Iomed, Inc.