Cleared Traditional

K896444 - IONTOPHORESIS DEVICE - ELECTRODE RH 800

K896444 is an FDA 510(k) clearance for IONTOPHORESIS DEVICE - ELECTRODE RH 800, manufactured by Iomed, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K896444 · Iomed, Inc. · Physical Medicine device
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May 1990
Decision
182d
Days
Class 2
Risk

K896444 is an FDA 510(k) clearance for the IONTOPHORESIS DEVICE - ELECTRODE RH 800. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 10, 1990 after a review of 182 days - an extended review 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: 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 Iomed, Inc. devices

FDA 510(k) Submission Details - K896444

510(k) Number K896444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received November 09, 1989
Decision Date May 10, 1990
Days to Decision 182 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
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 42
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K896444.
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015 · Empi · Nov 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014 · Empi · Oct 1991
IONTOPHORESIS DEVICE
K903093 · Empi · Oct 1990
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