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FDA 510(k)

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

K-Number: K190009 · 2019-12-02

ApplicantHong Qiangxing (Shenzhen) Electronics Limited
Decision Date2019-12-02
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

When was Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) approved by the FDA?

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

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

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited.

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.

Other Devices by Hong Qiangxing (Shenzhen) Electronics Limited

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Related Devices (Code: NUH)

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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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