Cleared Traditional

K912015 - TBD

K912015 is the FDA 510(k) clearance for TBD by Empi. It is a Class 2 Physical Medicine device (product code EGJ) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K912015 · Empi · Physical Medicine device
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Nov 1991
Decision
193d
Days
Class 2
Risk

K912015 is an FDA 510(k) clearance for the TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3. 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 November 15, 1991 after a review of 193 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

Submission Details

510(k) Number K912015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date November 15, 1991
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 K912015.
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · Empi · May 1997
MICROPHOR
K913601 · Life-Tech Intl., Inc. · Jul 1994
DUPEL IONTOPHORESIS DEVICE
K915444 · Empi · Jul 1994
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
K912014 · Empi · Oct 1991
IONTOPHORESIS DEVICE
K903093 · Empi · Oct 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · Empi · Feb 1990