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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 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 2025-12-23 under 510(k) 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. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K253740.

When did TENS&EMS (HZ9151B, HZ9151C, HZ9151D) receive FDA 510(k) clearance?

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

Who is the listed applicant for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

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&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D) 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.

K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMSK190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

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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.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K251958VEINOPLUS BackDynapulse MedicalK252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd.

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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