Cleared Traditional

K853633 - TENS CONDUCTIVE MEDIA PAD

K853633 is the FDA 510(k) clearance for TENS CONDUCTIVE MEDIA PAD by Alternative Design Systems, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K853633 · Alternative Design Systems, Inc. · Neurology device
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Dec 1985
Decision
95d
Days
Class 2
Risk

K853633 is an FDA 510(k) clearance for the TENS CONDUCTIVE MEDIA PAD. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Alternative Design Systems, Inc. (Carlstadt, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 95 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 Alternative Design Systems, Inc. devices

Submission Details

510(k) Number K853633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1985
Decision Date December 03, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 148d · This submission: 95d
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 107
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K853633.
TENZCARE SNAP ELECTRODE, NO. 6865
K863307 · 3M Company · Sep 1986
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · Valleylab, Inc. · Sep 1986
VERSA STIM
K862718 · Conmedcorp · Sep 1986
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984