Cleared Traditional

K961141 - EASY FLEX TENS/FES/MNS ELECTRODES 2 ROU...

K961141 is the FDA 510(k) clearance for EASY FLEX TENS/FES/MNS ELECTRODES 2 ROU... by Uni-Patch, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K961141 · Uni-Patch, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
50d
Days
Class 2
Risk

K961141 is an FDA 510(k) clearance for the EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Uni-Patch, Inc. (Wabasha, US). The FDA issued a Cleared decision on May 10, 1996 after a review of 50 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 Uni-Patch, Inc. devices

Submission Details

510(k) Number K961141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date May 10, 1996
Days to Decision 50 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
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 147
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K961141.
AMBU NEUROLINE GROUND
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K032278 · Ambu, Inc. · Mar 2004
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · Bio-Logic Systems Corp. · Jan 1996
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · Henley Intl. · Nov 1995
MEDI-TRAC EEG ELECTRODE
K950782 · Graphic Controls Corp. · Jun 1995