Cleared Traditional

K864032 - EM TENS WINDOW ELECTRODES

K864032 is the FDA 510(k) clearance for EM TENS WINDOW ELECTRODES by Electromed Intl., Ltd.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K864032 · Electromed Intl., Ltd. · Neurology device
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Dec 1986
Decision
68d
Days
Class 2
Risk

K864032 is an FDA 510(k) clearance for the EM TENS WINDOW ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Electromed Intl., Ltd. (Waltham, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 68 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.

View all Electromed Intl., Ltd. devices

Submission Details

510(k) Number K864032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date December 22, 1986
Days to Decision 68 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 148d · This submission: 68d
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 153
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K864032.
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
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K863307 · 3M Company · Sep 1986
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VERSA STIM
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