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510(k) K200561

Device
StimPlus Patch, StimPlus Patch, StimPlus Patch
Applicant
JKH Health Co., LTD
510(k) number
K200561
Product code
NUH  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-01
Date received
2020-03-04
Regulation
882.5890
Classification name
Stimulator, Nerve, Transcutaneous, Over-the-counter
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pu Jiang
Address
4-5f, Bldg. 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area, Shajing, Baoan Shenzhen CN 518104 518104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.2026-03-04
K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.2025-12-31
K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited2025-12-23
K251958VEINOPLUS BackDynapulse Medical2025-12-23
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd.2025-11-24
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4Everyway Medical Instruments Co.,Ltd2025-11-21
K243131Triathlon ProSigma Biomedical2025-11-07
K251429OTC 4-Channel Rechargeable TENS UnitChangsha Anxiang Medical Technology Co., Ltd.2025-08-28
K250784Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)Shenzhen Yicai Health Technology Co., Ltd.2025-08-21
K2511873 in 1 TENS UNIT (TC1241, TC2241, TS1241)Changsha Anxiang Medical Technology Co., Ltd.2025-07-28
K243856TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)Shenzhen Astec Technology Co., Ltd.2025-05-29
K250360TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-11
K250053TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-09
K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.2025-04-09
K250033Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)Guangzhou Pinzhi Medical Technology Co., Ltd.2025-04-07

Legacy Summary#

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FDA Review#

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