Cleared Traditional

K060236 - MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE

K060236 is an FDA 510(k) clearance for MW-1000 IONTOPHORETIC DRUG DELIVERY ELE..., 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 60-day FDA review.

K060236 · Iomed, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
60d
Days
Class 2
Risk

K060236 is an FDA 510(k) clearance for the MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE. 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 March 31, 2006 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060236

510(k) Number K060236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2006
Decision Date March 31, 2006
Days to Decision 60 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
56d faster than avg
Panel avg: 116d · This submission: 60d
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 K060236.
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
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
K052019 · North Coast Medical, Inc. · Nov 2005
DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · Dynatronics Corp. · Jan 2005
TRANSDERM IONTO SYSTEM, MK 2
K042590 · Mattioli Engineering Corp. · Oct 2004
K060236 · MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
Download PDF FDA Summary Iomed, Inc.