Cleared Traditional

K942718 - CLOTH TENS/BNES ELECTRODE

K942718 is an FDA 510(k) clearance for CLOTH TENS/BNES ELECTRODE, manufactured by Conmed Andover Medical, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K942718 · Conmed Andover Medical, Inc. · Neurology device
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Sep 1994
Decision
105d
Days
Class 2
Risk

K942718 is an FDA 510(k) clearance for the CLOTH TENS/BNES ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Conmed Andover Medical, Inc. (Haverhill, US). The FDA issued a Cleared decision on September 22, 1994 after a review of 105 days - within the typical 510(k) review window.

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 Conmed Andover Medical, Inc. devices

FDA 510(k) Submission Details - K942718

510(k) Number K942718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1994
Decision Date September 22, 1994
Days to Decision 105 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
43d faster than avg
Panel avg: 148d · This submission: 105d
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 315
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K942718.
ELECTROFLEX
K943126 · Medical Devices, Inc. · Dec 1994
ELECTRODE, CUTANEOUS
K933801 · Cadwell Laboratories, Inc. · Oct 1994
DANTEC 13R45 BAR ELECTRODE
K934580 · Dantec Medical, Inc. · Sep 1994
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc. · Sep 1994
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc. · Jul 1994
DISPOSABLE TAB ELECTRODE
K933803 · Cadwell Laboratories, Inc. · Jul 1994