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FDA 510(k)

TENS & PMS (Model: SM9126)

K-Number: K220150 · 2022-02-17

Decision Date2022-02-17
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Hong Qiangxing (Shenzhen) Electronics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.