Cleared Traditional

K160081 - TENS Electrodes

K160081 is an FDA 510(k) clearance for TENS Electrodes, manufactured by Cathay Manufacturing Corp.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K160081 · Cathay Manufacturing Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
278d
Days
Class 2
Risk

K160081 is an FDA 510(k) clearance for the TENS Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Cathay Manufacturing Corp. (Shanghai, CN). The FDA issued a Cleared decision on October 19, 2016 after a review of 278 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 Cathay Manufacturing Corp. devices

FDA 510(k) Submission Details - K160081

510(k) Number K160081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2016
Decision Date October 19, 2016
Days to Decision 278 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
130d slower than avg
Panel avg: 148d · This submission: 278d
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 219
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K160081.
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BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
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ASCEND ELECTRODE
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GARMENT ELECTRODES
K141076 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2014