Cleared Traditional

K032968 - TRSANSDERM IONTO SYSTEM

K032968 is an FDA 510(k) clearance for TRSANSDERM IONTO SYSTEM, manufactured by Mattioli Engineering Corp.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K032968 · Mattioli Engineering Corp. · Physical Medicine device
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Dec 2003
Decision
70d
Days
Class 2
Risk

K032968 is an FDA 510(k) clearance for the TRSANSDERM IONTO SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Mattioli Engineering Corp. (Beltsville, US). The FDA issued a Cleared decision on December 2, 2003 after a review of 70 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.

View all Mattioli Engineering Corp. devices

FDA 510(k) Submission Details - K032968

510(k) Number K032968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date December 02, 2003
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 43
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K032968.
DYNATRON ION IONTOPHORESIS ELECTRODE
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DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · Dynatronics Corp. · Jan 2005
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · Empi · Apr 2003
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
PHORESOR II,MODEL PM900
K982668 · Iomed, Inc. · Mar 1999