Cleared Traditional

K965194 - MEDICOM, TENS ELECTRODES

K965194 is an FDA 510(k) clearance for MEDICOM, manufactured by Medicotest A/S. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K965194 · Medicotest A/S · Neurology device
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Mar 1997
Decision
72d
Days
Class 2
Risk

K965194 is an FDA 510(k) clearance for the MEDICOM, TENS ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medicotest A/S (Washington, US). The FDA issued a Cleared decision on March 6, 1997 after a review of 72 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 Medicotest A/S devices

FDA 510(k) Submission Details - K965194

510(k) Number K965194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date March 06, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 148d · This submission: 72d
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 242
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K965194.
DREAM CATCHER
K972122 · Rest Technologies, Inc. · Aug 1997
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
K970639 · Medicotest, Inc. · May 1997
VALUETRODE
K970426 · Axelgaard Mfg. Co., Ltd. · May 1997
AQUABOND ELECTRODE
K964433 · Medibond , Ltd. · Jan 1997
EEG ELECTRODES
K962283 · Teca, Inc. · Dec 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · Aspect Medical Systems, Inc. · Oct 1996