FDA 510(k)

Electronic Pulse Stimulator

N.º K: K153520 · 2016-05-05

Fecha de decisión2016-05-05

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electronic Pulse Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K153520. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Electronic Pulse Stimulator?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K153520.

When did Electronic Pulse Stimulator receive FDA 510(k) clearance?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2016-05-05, under 510(k) number K153520.

Who is the listed applicant for Electronic Pulse Stimulator?

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

What is the FDA product code for Electronic Pulse Stimulator?

The FDA product code for Electronic Pulse Stimulator is NUH.

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Otros registros que enlistan a Jkh Health Co., Ltd. como solicitante

K253150Cryon-X Cold Compression K240788Ultrasound Stimulator K240986Cold Compression K240011Lymphedema Compression K223541Cold/Hot Compression K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304

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Dispositivos relacionados (Código: NUH)

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Fuente oficial

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