FDA 510(k)

TENS & PMS Unit

N.º K: K220005 · 2022-04-01

SolicitanteShenzhen Yuehua Xinsen Technology Co., Ltd.

Fecha de decisión2022-04-01

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

TENS & PMS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yuehua Xinsen Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-01 under 510(k) number K220005. 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 TENS & PMS Unit?

TENS & PMS Unit is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Shenzhen Yuehua Xinsen Technology Co., Ltd.. The 510(k) number is K220005.

When did TENS & PMS Unit receive FDA 510(k) clearance?

TENS & PMS Unit received FDA 510(k) clearance on 2022-04-01, under 510(k) number K220005.

Who is the listed applicant for TENS & PMS Unit?

The FDA 510(k) record lists Shenzhen Yuehua Xinsen Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS & PMS Unit?

The FDA product code for TENS & PMS Unit is NUH.

Dispositivos relacionados (Código: NUH)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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