FDA 510(k)

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

N.º K: K253740 · 2025-12-23

SolicitanteHong Qiangxing (Shenzhen) Electronics Limited

Fecha de decisión2025-12-23

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253740. 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&EMS (HZ9151B, HZ9151C, HZ9151D)?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K253740.

When did TENS&EMS (HZ9151B, HZ9151C, HZ9151D) receive FDA 510(k) clearance?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253740.

Who is the listed applicant for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is NUH.

Otros registros que enlistan a Hong Qiangxing (Shenzhen) Electronics Limited como solicitante

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.

K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.