Cleared Traditional

K954126 - TRANSQ ELECTRODE PHORESOR II

K954126 is an FDA 510(k) clearance for TRANSQ ELECTRODE PHORESOR II, manufactured by Iomed, Inc.. The device is a Class 2 Physical Medicine device with product code KTB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K954126 · Iomed, Inc. · Physical Medicine device
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Jan 1996
Decision
140d
Days
Class 2
Risk

K954126 is an FDA 510(k) clearance for the TRANSQ ELECTRODE PHORESOR II. Classified as Device, Iontophoresis, Specific Uses (product code KTB), Class II - Special Controls.

Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 19, 1996 after a review of 140 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 - K954126

510(k) Number K954126 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 01, 1995
Decision Date January 19, 1996
Days to Decision 140 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 slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTB Device Classification - Class 2, Special Controls

Product Code KTB Device, Iontophoresis, Specific 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 - KTB Device, Iontophoresis, Specific Uses

All 8
Devices cleared under the same product code (KTB) and FDA review panel - the closest regulatory comparables to K954126.
TRANSQ3
K001522 · Iomed, Inc. · Oct 2000
PHORESOR MODEL PM2000
K001410 · Iomed, Inc. · Aug 2000
PHORESOR II, MODEL PM900
K974855 · Iomed, Inc. · Mar 1998
CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
K895775 · Medtronic Vascular · Apr 1990
IONOPHORELIC SWEAT STIM. CHLORIDE-
K832059 · Medtronic Vascular · Aug 1983