Cleared Traditional

K943126 - ELECTROFLEX

K943126 is an FDA 510(k) clearance for ELECTROFLEX, manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K943126 · Medical Devices, Inc. · Neurology device
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Dec 1994
Decision
159d
Days
Class 2
Risk

K943126 is an FDA 510(k) clearance for the ELECTROFLEX. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 159 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K943126

510(k) Number K943126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1994
Decision Date December 05, 1994
Days to Decision 159 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 148d · This submission: 159d
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 156
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K943126.
RING ELECTRODE
K933805 · Cadwell Laboratories, Inc. · Dec 1994
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K944603 · Conmedcorp · Dec 1994
SMARTBRACE ELECTRODE
K940012 · Medical Devices, Inc. · Dec 1994
ELECTRODE, CUTANEOUS
K933801 · Cadwell Laboratories, Inc. · Oct 1994
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc. · Sep 1994
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc. · Jul 1994