FDA 510(k)

STOPWET iontophoresis apparatus (SW01)

N.º K: K242041 · 2025-04-01

SolicitanteTaiwan Medical Electronics Co., Ltd.

Fecha de decisión2025-04-01

Código de productoEGJ

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

STOPWET iontophoresis apparatus (SW01) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K242041. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the STOPWET iontophoresis apparatus (SW01)?

STOPWET iontophoresis apparatus (SW01) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Taiwan Medical Electronics Co., Ltd.. The 510(k) number is K242041.

When did STOPWET iontophoresis apparatus (SW01) receive FDA 510(k) clearance?

STOPWET iontophoresis apparatus (SW01) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K242041.

Who is the listed applicant for STOPWET iontophoresis apparatus (SW01)?

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

What is the FDA product code for STOPWET iontophoresis apparatus (SW01)?

The FDA product code for STOPWET iontophoresis apparatus (SW01) is EGJ.

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Fuente oficial

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