FDA 510(k)

TENS & PMS (Model: SM9126)

Número K: K220150 · 2022-02-17

RequerenteHong Qiangxing (Shenzhen) Electronics Limited

Data da decisão2022-02-17

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS & PMS (Model: SM9126) 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 2022-02-17 under 510(k) number K220150. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TENS & PMS (Model: SM9126)?

TENS & PMS (Model: SM9126) is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220150.

When did TENS & PMS (Model: SM9126) receive FDA 510(k) clearance?

TENS & PMS (Model: SM9126) received FDA 510(k) clearance on 2022-02-17, under 510(k) number K220150.

Who is the listed applicant for TENS & PMS (Model: SM9126)?

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 & PMS (Model: SM9126)?

The FDA product code for TENS & PMS (Model: SM9126) is NUH.

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Outros registros que listam Hong Qiangxing (Shenzhen) Electronics Limited como candidato(a)

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

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