JKH Stimulator Plus

FDA 510(k) K191151 · Jkh USA, LLC

Substantially Equivalent

510(k) numberK191151

Submission

Device name
JKH Stimulator Plus
Applicant
Jkh USA, LLC
Diamond Bar, CA, US
Received
May 1, 2019
Decision date
June 21, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 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)DeviceApplicantDecision
K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional Shenzhen Osto Medical Technology Co.,Ltd09/06/2026SE
K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional Shenzhen Dongdixin Technology Co., Ltd.06/26/2026SE
K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional Hivox Biotek, Inc.06/16/2026SE
K253896TENS/EMS device (GUSE01)NUH · Traditional Globalcare Medical Technology Co., Ltd.03/04/2026SE
K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional Shenzhen Jiantuo Electronics Co., Ltd.12/31/2025SE
K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional Hong Qiangxing (Shenzhen) Electronics Limited12/23/2025SE
K251958VEINOPLUS BackNUH · Traditional Dynapulse Medical12/23/2025SE
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.11/24/2025SE
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

More from Sigma Biomedical

510(k)DeviceDecision
K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS…FLL · Traditional 08/31/2021SE
K203635Patient Monitoring CablesDSA · Traditional 02/05/2021SE
K203652Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff…DXQ · Traditional 01/06/2021SE
K202851Spo2 SensorDQA · Traditional 11/27/2020SE
K201645Massage Compression BootsIRP · Traditional 09/15/2020SE
K201470Disposable Medical Face MaskFXX · Traditional 09/08/2020SE
K182671Medi-Direct TENS PenNUH · Traditional 09/21/2019SE
K182203JKH Stimulator PlusNUH · Traditional 03/14/2019SE

Questions and answers

When was JKH Stimulator Plus cleared by the FDA?

JKH Stimulator Plus (K191151) received a 510(k) decision of Substantially Equivalent on June 21, 2019, 51 days after the submission was received.

What is the product code of K191151?

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