Cleared Traditional

K903093 - IONTOPHORESIS DEVICE

K903093 is the FDA 510(k) clearance for IONTOPHORESIS DEVICE by Empi. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K903093 · Empi · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
90d
Days
Class 2
Risk

K903093 is an FDA 510(k) clearance for the IONTOPHORESIS DEVICE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on October 11, 1990 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

Submission Details

510(k) Number K903093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 13, 1990
Decision Date October 11, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
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.

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 26
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K903093.
DUPEL IONTOPHORESIS DEVICE
K915444 · Empi · Jul 1994
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015 · Empi · Nov 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014 · Empi · Oct 1991
TBD IONTOPHORESIS ELECTRODE
K896703 · Empi · Feb 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · Henley Intl. · Feb 1990
XOMED IONESTHETIZER(TM)
K884834 · Xomed, Inc. · Feb 1989