Cleared Traditional

K912014 - TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2

K912014 is an FDA 510(k) clearance for TBD, 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 175-day FDA review.

K912014 · Empi · Physical Medicine device
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Oct 1991
Decision
175d
Days
Class 2
Risk

K912014 is an FDA 510(k) clearance for the TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2. 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 28, 1991 after a review of 175 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 Empi devices

FDA 510(k) Submission Details - K912014

510(k) Number K912014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date October 28, 1991
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
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 K912014.
TRANSQ 2
K914264 · Iomed, Inc. · Dec 1991
IONTOPHORESIS DEVICE, MODIFICATION
K914621 · Iomed, Inc. · Dec 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015 · Empi · Nov 1991
IONTOPHORESIS DEVICE
K903093 · Empi · Oct 1990
IONTOPHORESIS DEVICE - ELECTRODE RH 800
K896444 · Iomed, Inc. · May 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · Empi · Feb 1990