Tens&Ems (HZ9151B, HZ9151C, HZ9151D)

Q: What is the product code of K253740?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K253740 · Hong Qiangxing (Shenzhen) Electronics Limited

Substantially Equivalent

510(k) numberK253740

Submission

Device name: Tens&Ems (HZ9151B, HZ9151C, HZ9151D)
Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
Shenzhen, CN
Received: November 24, 2025
Decision date: December 23, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other 510(k)s with product code NUH

510(k)	Device	Applicant	Decision
K261131	Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional	Shenzhen Osto Medical Technology Co.,Ltd	09/06/2026SE
K260412	TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional	Shenzhen Dongdixin Technology Co., Ltd.	06/26/2026SE
K260425	TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional	Hivox Biotek, Inc.	06/16/2026SE
K253896	TENS/EMS device (GUSE01)NUH · Traditional	Globalcare Medical Technology Co., Ltd.	03/04/2026SE
K253305	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional	Shenzhen Jiantuo Electronics Co., Ltd.	12/31/2025SE
K251958	VEINOPLUS BackNUH · Traditional	Dynapulse Medical	12/23/2025SE
K252688	Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional	Bozhou Rongjian Medical Appliance Co., Ltd.	11/24/2025SE
K251856	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special	Everyway Medical Instruments Co.,Ltd	11/21/2025SE
K243131	Triathlon ProNUH · Traditional	Sigma Biomedical	11/07/2025SE
K251429	OTC 4-Channel Rechargeable TENS UnitNUH · Special	Changsha Anxiang Medical Technology Co., Ltd.	08/28/2025SE

More from Changsha Anxiang Medical Technology Co., Ltd.

510(k)	Device	Decision
K220283	TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)NUH · Traditional	05/02/2022SE
K220152	TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)NUH · Traditional	04/19/2022SE
K220150	TENS & PMS (Model: SM9126)NUH · Traditional	02/17/2022SE
K201354	TENS & PMSNGX · Traditional	12/11/2020SE
K190009	Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)NUH · Traditional	12/02/2019SE
K183154	SM ElectrodesGXY · Traditional	03/26/2019SE
K133108	Fit BeltNGX · Traditional	08/05/2014SE
K121719	SM TENS & PMSNGX · Traditional	05/10/2013SE

Questions and answers

When was Tens&Ems (HZ9151B, HZ9151C, HZ9151D) cleared by the FDA?

Tens&Ems (HZ9151B, HZ9151C, HZ9151D) (K253740) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 29 days after the submission was received.

What is the product code of K253740?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.