Cleared Traditional

K060814 - DYNATRON ION IONTOPHORESIS ELECTRODE (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060814 · Dynatronics Corp. · Physical Medicine device
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Jun 2006
Decision
79d
Days
Class 2
Risk

K060814 is an FDA 510(k) clearance for the DYNATRON ION IONTOPHORESIS ELECTRODE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on June 14, 2006 after a review of 79 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 Dynatronics Corp. devices

Submission Details

510(k) Number K060814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date June 14, 2006
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 72
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K060814.
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Dermadry
K192749 · Dermadry Laboratories, Inc. · Feb 2020
Saalio
K191436 · Saalmann Medical GmbH & Co. KG · Oct 2019
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015