Cleared Traditional

K970491 - DUPEL II BUFFERED IONTOPHORESIS ELECTRODES

K970491 is an FDA 510(k) clearance for DUPEL II BUFFERED IONTOPHORESIS ELECTRODES, 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 109-day FDA review.

K970491 · Empi · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
109d
Days
Class 2
Risk

K970491 is an FDA 510(k) clearance for the DUPEL II BUFFERED IONTOPHORESIS ELECTRODES. 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 30, 1997 after a review of 109 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 - K970491

510(k) Number K970491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date May 30, 1997
Days to Decision 109 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
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 K970491.
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
PHORESOR II,MODEL PM900
K982668 · Iomed, Inc. · Mar 1999
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · Empi · Dec 1998
MD-1A GALVANIC UNIT
K964208 · R. A. Fischer Co. Corp. · Apr 1997
IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
K946337 · Skylark Device Co., Ltd. · Dec 1995
DYNAPHOR(TM) TWO
K935868 · Maxxim Medical · Mar 1995