FDA 510(k)

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)

Numéro K : K220152 · 2022-04-19

DemandeurHong Qiangxing (Shenzhen) Electronics Limited

Date de décision2022-04-19

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) 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 2022-04-19 under 510(k) number K220152. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)?

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220152.

When did TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) receive FDA 510(k) clearance?

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) received FDA 510(k) clearance on 2022-04-19, under 510(k) number K220152.

Who is the listed applicant for TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)?

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:SM9089, SM9587, SM9592, SM9555)?

The FDA product code for TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) is NUH.

Essais cliniques associés

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Autres dossiers indiquant Hong Qiangxing (Shenzhen) Electronics Limited en tant que demandeur

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

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Dispositifs connexes (Code : NUH)

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Source officielle

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