Cleared Traditional

Electrotherapy Electrodes

K250841 · Baisheng Medical Co., Ltd. · Neurology
Aug 2025
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K250841 is an FDA 510(k) clearance for the Electrotherapy Electrodes, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Baisheng Medical Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on August 13, 2025, 146 days after receiving the submission on March 20, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K250841 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2025
Decision Date August 13, 2025
Days to Decision 146 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

Similar Devices — GXY Electrode, Cutaneous

All 430
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
K260453 · Bionit Labs Srl · Mar 2026
Ceribell Instant EEG Headset
K254033 · Ceribell, Inc. · Feb 2026
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · Ceribell, Inc. · Oct 2025
IceCap product line
K243788 · Bioserenity Medical Devices Group · Mar 2025
Delphi MCS Electrode Cap
K243243 · Quantalx Neuroscience, Ltd. · Feb 2025
Electrode Pad
K241512 · Shenzhen Deliduo Medical Technology Co.,Ltd · Jan 2025

More from Baisheng Medical Co., Ltd.

View all
Electrosurgical Pads
K251235 · GEI · Jun 2025
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1
K233615 · GEI · Jan 2024
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)
K221815 · GEI · Nov 2022
OBS Electrosurgical Generator (Model: OBS-350A)
K162034 · GEI · Jan 2017