Cleared Traditional

K030395 - EMPI ACTION PATCH IONTOPHORESIS SYSTEM

K030395 is an FDA 510(k) clearance for EMPI ACTION PATCH IONTOPHORESIS SYSTEM, manufactured by Empi. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K030395 · Empi · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
62d
Days
Class 2
Risk

K030395 is an FDA 510(k) clearance for the EMPI ACTION PATCH IONTOPHORESIS SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Empi (Washington, US). The FDA issued a Cleared decision on April 8, 2003 after a review of 62 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 - K030395

510(k) Number K030395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2003
Decision Date April 08, 2003
Days to Decision 62 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
54d faster than avg
Panel avg: 116d · This submission: 62d
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 69
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K030395.
E-STRIP
K031769 · Eemso, Inc. · Oct 2003
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
K031053 · Selectivemed Components, Inc. · May 2003
MINIPHYSIONIZER 2.0 AND ELECTRODES
K022950 · Physion, Inc. · Apr 2003
MEDION 6000
K020476 · Selectivemed Components, Inc. · May 2002
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
K000574 · Wr Medical Electronics Co. · Aug 2000
IO-DRIVE
K993081 · Selectivemed Components, Inc. · Mar 2000
K030395 · EMPI ACTION PATCH IONTOPHORESIS SYSTEM
Download PDF FDA Summary Empi