Cleared Traditional

K924473 - DISPOSABLE THERAPY ELECTRODE

K924473 is the FDA 510(k) clearance for DISPOSABLE THERAPY ELECTRODE by Zimmer Elektromedizin GmbH. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K924473 · Zimmer Elektromedizin GmbH · Neurology device
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May 1993
Decision
261d
Days
Class 2
Risk

K924473 is an FDA 510(k) clearance for the DISPOSABLE THERAPY ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (Irvine, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 261 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer Elektromedizin GmbH devices

Submission Details

510(k) Number K924473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date May 19, 1993
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 148d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

All 147
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K924473.
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
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K933814 · Storz Instrument Co. · Dec 1993
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K915864 · Henley Intl. · Jul 1993
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
TBD TENS REUSABLE ELECTRODE
K902195 · Empi · Jun 1990
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · Empi · Mar 1990