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Electrodes Pad

by Shenzhen Bestpad Technology Development Co., Ltd.

510(k) K190700

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK190700 Date14 Jun 2019ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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

Overview

AI-generated summary, 23 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 Electrodes Pad is a cutaneous electrode device used for electrical stimulation or recording applications. It is designed to be placed on the skin to facilitate the transmission of electrical signals between a device and the body. The device is classified under product code GXY as a Class II medical device with special controls.

The device is supplied by Shenzhen Bestpad Technology Development Co., Ltd. and is intended for use in neurology settings. It is regulated under 21 CFR 882.1320 as a cutaneous electrode. The device received FDA 510(k) clearance under k-number K190700, with a decision date of June 14, 2019. Storage conditions, sterility, and reusability details are not specified in the provided data.

Questions

AI-generated answers, 23 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 is the Electrodes Pad used for?

    The Electrodes Pad is a cutaneous electrode designed to be placed on the skin to facilitate the transmission of electrical signals between a device and the body. It is intended for use in electrical stimulation or recording applications, particularly within neurology settings.

  • How is the Electrodes Pad supplied?

    The Electrodes Pad is supplied by Shenzhen Bestpad Technology Development Co., Ltd., located in Shenzhen, China. The specific packaging, quantity per unit, or shipping configuration is not detailed in the available regulatory data.

  • Is the Electrodes Pad sterile or single-use?

    The provided regulatory data does not specify whether the Electrodes Pad is supplied sterile, intended for single use, or designed for reuse. These details would typically be found in the manufacturer's labeling or product insert, which are not included in the current dataset.

  • What is the regulatory classification of this device?

    The Electrodes Pad is classified as a Class II medical device under product code GXY. It is regulated under 21 CFR 882.1320 as a cutaneous electrode and received FDA 510(k) clearance under k-number K190700 with a decision date of June 14, 2019.

  • What are the storage requirements for the Electrodes Pad?

    Specific storage conditions for the Electrodes Pad are not documented in the provided regulatory submission data. Users should consult the manufacturer’s instructions for storage recommendations, which may include temperature, humidity, or light exposure limitations not captured in the 510(k) summary.