Cleared Abbreviated

COMFORT/IO IONTOPHORESIS ELECTRODES (K060579) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K060579 · Pepin Mfg., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
45d
Days
Class 2
Risk

K060579 is an FDA 510(k) clearance for the COMFORT/IO IONTOPHORESIS ELECTRODES. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Pepin Mfg., Inc. (Stoughton, US). The FDA issued a Cleared decision on April 20, 2006 after a review of 45 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pepin Mfg., Inc. devices

Submission Details

510(k) Number K060579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2006
Decision Date April 20, 2006
Days to Decision 45 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Standards-based clearance path.

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 72
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K060579.
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