Skip to content

Wandy Self-Adhesive Neurostimulation Electrode

by Wandy Rubber Industrial Co., Ltd

510(k) K002219

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K002219↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK002219 Date2 Feb 2001ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FDA applicant
Wandy Rubber Industrial Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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 Wandy Self-Adhesive Neurostimulation Electrode is a self-adhesive electrode designed for transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). It delivers electrical impulses to the nervous system or muscles for therapeutic purposes, such as pain relief or muscle stimulation, adhering directly to the skin without requiring additional fixation.

This device is supplied as a single-use, sterile electrode intended for clinical use in settings such as hospitals, clinics, or home care. It is classified under product code GXY and adheres to FDA 510(k) clearance and MDR requirements. The electrode is non-magnetic and compatible with MRI environments when not in use, with sizes and configurations specified in the manufacturer’s documentation.

Other devices from Wandy Rubber Industrial Co., Ltd

Questions

AI-generated answers, 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.

  • What therapeutic applications is this electrode designed for?

    This electrode is specifically designed for transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). It delivers electrical impulses to the skin to help manage pain or stimulate muscles, making it suitable for therapeutic uses like pain relief or muscle rehabilitation in clinical or home settings.

  • Is this electrode reusable, or is it intended for single-use only?

    The Wandy Self-Adhesive Neurostimulation Electrode is explicitly labeled as a single-use device. It is supplied sterile and intended for one-time clinical use to ensure patient safety and hygiene.

  • Can this electrode be used in an MRI environment, and what precautions should be taken?

    Yes, the electrode is non-magnetic and compatible with MRI environments when not in use. However, it should not be used *during* MRI procedures, as electrical stimulation could interfere with imaging or pose safety risks. Always follow facility protocols for MRI-safe devices.

  • How is the electrode secured to the skin, and does it require additional fixation?

    The electrode is self-adhesive, meaning it sticks directly to the skin without needing tape, straps, or other fixation methods. This design simplifies application and reduces patient discomfort.

  • What regulatory pathways does this device follow, and which committee reviewed it?

    This device follows the FDA 510(k) clearance process and is classified under product code GXY. It was reviewed by the Neurology (NE) Advisory Committee and determined to be substantially equivalent to a predicate device, with a traditional clearance route (K002219). It also complies with MDR (Medical Device Regulation) requirements.