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FDA 510(k)

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

K-Number: K220152 · 2022-04-19

ApplicantHong Qiangxing (Shenzhen) Electronics Limited
Decision Date2022-04-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) is a medical device manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2022-04-19 under approval number K220152. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220152.

When was TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) approved by the FDA?

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

What company makes TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)?

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited.

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.

Other Devices by Hong Qiangxing (Shenzhen) Electronics Limited

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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