Cleared Traditional

K070427 - DUPEL TRANSPORT IONTOPHORESIS SYSTEM

K070427 is an FDA 510(k) clearance for DUPEL TRANSPORT IONTOPHORESIS SYSTEM, manufactured by Empi. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K070427 · Empi · Physical Medicine device
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May 2007
Decision
90d
Days
Class 2
Risk

K070427 is an FDA 510(k) clearance for the DUPEL TRANSPORT IONTOPHORESIS SYSTEM. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Empi (St. Paul, US). The FDA issued a Cleared decision on May 14, 2007 after a review of 90 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 Empi devices

FDA 510(k) Submission Details - K070427

510(k) Number K070427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2007
Decision Date May 14, 2007
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 48
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K070427.
TULA IONTOPHORESIS SYSTEM
K110636 · Acclarent, Inc. · Jun 2011
IONTOPHORESIS SYSTEM
K073276 · Acclarent, Inc. · Mar 2008
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K072946 · Empi · Nov 2007
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
K063465 · Iomed, Inc. · Feb 2007
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814 · Dynatronics Corp. · Jun 2006
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236 · Iomed, Inc. · Mar 2006