Cleared Traditional

K890614 - EMPI MULTIDAY TENS DISPOSABLE ELECTRODE

K890614 is an FDA 510(k) clearance for EMPI MULTIDAY TENS DISPOSABLE ELECTRODE, manufactured by Empi. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K890614 · Empi · Neurology device

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Mar 1989

Decision

37d

Days

Class 2

Risk

K890614 is an FDA 510(k) clearance for the EMPI MULTIDAY TENS DISPOSABLE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K890614

510(k) Number	K890614 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 1989
Decision Date	March 16, 1989
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

112d faster than avg

Panel avg: 149d · This submission: 37d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 413

Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K890614.

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INDICATENS INDICATOR ELECTRODE MODEL 2

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EMPI ISLAND TENS ELECTRODE

K890605 · Empi · Mar 1989

EMPI REUSEABLE PIN-STYLE TENS ELECTRODE

K890747 · Empi · Mar 1989

DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS

K890710 · Somatics, Inc. · Mar 1989

BIOTENS

K884814 · Trekk Intl. · Feb 1989

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K890614

Empi

Arden Hills, MN · US

STACY MATTSON

Regulatory profile

60 submissions 56 cleared

93% clearance rate · Active in Neurology

View all devices by Empi →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: March 16, 1989. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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