FDA 510(k)

Electrotherapy Electrodes

K-Number: K250841 · 2025-08-13

Decision Date2025-08-13

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Electrotherapy Electrodes is a medical device manufactured by Baisheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under approval number K250841. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrotherapy Electrodes?

Electrotherapy Electrodes is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Baisheng Medical Co., Ltd.. The 510(k) number is K250841.

When was Electrotherapy Electrodes approved by the FDA?

Electrotherapy Electrodes received FDA 510(k) clearance on 2025-08-13, under approval number K250841.

What company makes Electrotherapy Electrodes?

Electrotherapy Electrodes is manufactured by Baisheng Medical Co., Ltd..

What is the FDA product code for Electrotherapy Electrodes?

The FDA product code for Electrotherapy Electrodes is GXY.

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Other Devices by Baisheng Medical Co., Ltd.

K162034OBS Electrosurgical Generator (Model: OBS-350A) K221815Electrosurgical 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) K233615Electrosurgical 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 K251235Electrosurgical Pads

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.