Cleared Traditional

K000574 - IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)

K000574 is an FDA 510(k) clearance for IONTOPHORETIC DRUG DELIVERY ELECTRODE, manufactured by Wr Medical Electronics Co.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K000574 · Wr Medical Electronics Co. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
169d
Days
Class 2
Risk

K000574 is an FDA 510(k) clearance for the IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE). Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Wr Medical Electronics Co. (Stillwater, US). The FDA issued a Cleared decision on August 9, 2000 after a review of 169 days - an extended review cycle.

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.

View all Wr Medical Electronics Co. devices

FDA 510(k) Submission Details - K000574

510(k) Number K000574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date August 09, 2000
Days to Decision 169 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
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 49
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K000574.
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236 · Iomed, Inc. · Mar 2006
DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · Dynatronics Corp. · Jan 2005
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · Empi · Apr 2003
IO-DRIVE
K993081 · Selectivemed Components, Inc. · Mar 2000
IONTOPATCH
K992708 · Birch Point Medical, Inc. · Feb 2000
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999