Cleared Traditional

K080580 - COMFORT IONTOPHORESIS ELECTRODES/ BUFFE...

K080580 is the FDA 510(k) clearance for COMFORT IONTOPHORESIS ELECTRODES/ BUFFE... by Axelgaard Mfg. Co., Ltd.. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K080580 · Axelgaard Mfg. Co., Ltd. · Physical Medicine device
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Jun 2008
Decision
107d
Days
Class 2
Risk

K080580 is an FDA 510(k) clearance for the COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT,.... Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Axelgaard Mfg. Co., Ltd. (Fallbrook, US). The FDA issued a Cleared decision on June 18, 2008 after a review of 107 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 Axelgaard Mfg. Co., Ltd. devices

Submission Details

510(k) Number K080580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date June 18, 2008
Days to Decision 107 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
8d faster than avg
Panel avg: 115d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K080580.
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835 · Hightech Development · Jun 2018
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015
TULA IONTOPHORESIS SYSTEM
K110636 · Acclarent, Inc. · Jun 2011
IONTOPHORESIS SYSTEM
K073276 · Acclarent, Inc. · Mar 2008
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · Empi · Nov 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · Empi · May 2007