Cleared Traditional

K043047 - DYNATRON IBOX IONTOPHORESIS DEVICE

K043047 is an FDA 510(k) clearance for DYNATRON IBOX IONTOPHORESIS DEVICE, manufactured by Dynatronics Corp.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K043047 · Dynatronics Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
64d
Days
Class 2
Risk

K043047 is an FDA 510(k) clearance for the DYNATRON IBOX IONTOPHORESIS DEVICE. 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 January 7, 2005 after a review of 64 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 - K043047

510(k) Number K043047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 04, 2004
Decision Date January 07, 2005
Days to Decision 64 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 116d · This submission: 64d
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 67
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K043047.
COMFORT/IO IONTOPHORESIS ELECTRODES
K060579 · Pepin Mfg., Inc. · Apr 2006
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236 · Iomed, Inc. · Mar 2006
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
K052019 · North Coast Medical, Inc. · Nov 2005
TRANSDERM IONTO SYSTEM, MK 2
K042590 · Mattioli Engineering Corp. · Oct 2004
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
K041101 · Medical Adhesiveonline, LLC · Jul 2004
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
K040495 · Naimco, Inc. · Apr 2004
K043047 · DYNATRON IBOX IONTOPHORESIS DEVICE
Download PDF FDA Summary Dynatronics Corp.