FDA 510(k)

Electrotherapy Electrodes

N.º K: K250841 · 2025-08-13

Fecha de decisión2025-08-13

Código de productoGXY

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

What is the Electrotherapy Electrodes?

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

When did Electrotherapy Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Electrotherapy Electrodes?

The FDA 510(k) record lists Baisheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrotherapy Electrodes?

The FDA product code for Electrotherapy Electrodes is GXY.

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Otros registros que enlistan a Baisheng Medical Co., Ltd. como solicitante

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

Dispositivos relacionados (Código: GXY)

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Fuente oficial

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