LL TENS 160A, LL TENS 160B

Q: What is the product code of K152374?

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) K152374 · Fuji Dynamics , Ltd.

Substantially Equivalent

510(k) numberK152374

Submission

Device name: LL TENS 160A, LL TENS 160B
Applicant: Fuji Dynamics , Ltd.
Hong Kong, CN
Received: August 21, 2015
Decision date: January 13, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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
K253740	Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional	Hong Qiangxing (Shenzhen) Electronics Limited	12/23/2025SE
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

More from Sigma Biomedical

510(k)	Device	Decision
K161055	Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/…KPI · Traditional	07/12/2016SE
K152676	FD TENS 2090, FD TENS 2095GZJ · Traditional	01/22/2016SE
K111654	FD TENS 2070GZJ · Traditional	03/01/2012SE
K111645	FD TENS 2050 or Slide TENS Model FD2050GZJ · Traditional	11/09/2011SE
K092780	Inf 4160 Plus, Model D-FJ31FLIH · Traditional	01/07/2010SE
K063642	FD EMS, Model # D-FJ30EIPF · Traditional	12/13/2007SE
K052813	FD TENS 2030, Model DFJ24TGZJ · Traditional	01/25/2006SE
K043407	Inf 4160, Model D-FJ27FLIH · Traditional	02/11/2005SE
K041164	L-TensGZJ · Traditional	05/20/2004SE
K994266	Fdtens 2010GZJ · Traditional	07/06/2000SE

Questions and answers

When was LL TENS 160A, LL TENS 160B cleared by the FDA?

LL TENS 160A, LL TENS 160B (K152374) received a 510(k) decision of Substantially Equivalent on January 13, 2016, 145 days after the submission was received.

What is the product code of K152374?

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