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TENS Electrodes

by Cathay Manufacturing Corp.

510(k) K160081

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160081↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160081 Date19 Oct 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160081 decided 19 Oct 2016 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
GXY
Device class
Class II
Regulation
21 CFR Part 882.1320
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TENS Electrodes are a type of Transcutaneous Electrical Nerve Stimulation (TENS) Electrode designed to deliver low-voltage electrical currents for pain management. These electrodes are applied to the skin to modulate nerve signals and provide relief for acute or chronic pain conditions, adhering to the principles of neuromodulation therapy.

These electrodes are supplied as single-use, sterile adhesive pads intended for external application. They are classified under the GXY product code and are regulated under FDA 510K and MDR compliance. Each electrode is pre-packaged for clinical use, ensuring compatibility with standard TENS units and adherence to regulatory standards for electrical safety and medical device performance.

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

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