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FDA 510(k)

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

K-Number: K253740 · 2025-12-23

ApplicantHong Qiangxing (Shenzhen) Electronics Limited
Decision Date2025-12-23
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is a medical device manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2025-12-23 under approval number K253740. 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&EMS (HZ9151B, HZ9151C, HZ9151D)?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K253740.

When was TENS&EMS (HZ9151B, HZ9151C, HZ9151D) approved by the FDA?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) received FDA 510(k) clearance on 2025-12-23, under approval number K253740.

What company makes TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited.

What is the FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D) 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) K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) K220150TENS & PMS (Model: SM9126)

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Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

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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