Cleared Traditional

K040495 - NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405

K040495 is an FDA 510(k) clearance for NAIMCO, manufactured by Naimco, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K040495 · Naimco, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
56d
Days
Class 2
Risk

K040495 is an FDA 510(k) clearance for the NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401.... Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Naimco, Inc. (Chattanooga, US). The FDA issued a Cleared decision on April 22, 2004 after a review of 56 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 Naimco, Inc. devices

FDA 510(k) Submission Details - K040495

510(k) Number K040495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date April 22, 2004
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K040495.
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
IONTOPATCH
K992708 · Birch Point Medical, Inc. · Feb 2000