FDA 510(k)

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

N.º K: K190009 · 2019-12-02

SolicitanteHong Qiangxing (Shenzhen) Electronics Limited

Fecha de decisión2019-12-02

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) 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 2019-12-02 under 510(k) number K190009. 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 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)?

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K190009.

When did Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) receive FDA 510(k) clearance?

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) received FDA 510(k) clearance on 2019-12-02, under 510(k) number K190009.

Who is the listed applicant for Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)?

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 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)?

The FDA product code for Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) is NUH.

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

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K183154SM Electrodes

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Fuente oficial

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