Cleared Traditional

K914621 - IONTOPHORESIS DEVICE, MODIFICATION

K914621 is an FDA 510(k) clearance for IONTOPHORESIS DEVICE, 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 100-day FDA review.

K914621 · Iomed, Inc. · Physical Medicine device
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Dec 1991
Decision
100d
Days
Class 2
Risk

K914621 is an FDA 510(k) clearance for the IONTOPHORESIS DEVICE, MODIFICATION. 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 December 20, 1991 after a review of 100 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 Iomed, Inc. devices

FDA 510(k) Submission Details - K914621

510(k) Number K914621 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 11, 1991
Decision Date December 20, 1991
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
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 K914621.
RH-806, MODEL TRANSQ
K925800 · Iomed, Inc. · Jul 1994
RH-801, MODEL TRANSQ
K925806 · Iomed, Inc. · Jul 1994
TRANSQ 2
K914264 · Iomed, Inc. · Dec 1991
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