Cleared Traditional

K052019 - NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE

K052019 is an FDA 510(k) clearance for NORTH COAST BUFFERED IONTOPHORESIS ELEC..., manufactured by North Coast Medical, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K052019 · North Coast Medical, Inc. · Physical Medicine device
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Nov 2005
Decision
101d
Days
Class 2
Risk

K052019 is an FDA 510(k) clearance for the NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by North Coast Medical, Inc. (Morgan Hill, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 101 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.

View all North Coast Medical, Inc. devices

FDA 510(k) Submission Details - K052019

510(k) Number K052019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date November 04, 2005
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 47
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K052019.
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
K063465 · Iomed, Inc. · Feb 2007
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814 · Dynatronics Corp. · Jun 2006
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