Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA product code NUH · 200 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5890
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2004-08-25 – 2026-09-06

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

NUH 2026-09-06

Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)

Applicant Shenzhen Osto Medical Technology Co.,Ltd

K number K261131

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NUH 2026-06-26

TENS 7000 Rechargeable 4 Channel (TENS 7000H)

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K260412

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NUH 2026-06-16

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

Applicant Hivox Biotek, Inc.

K number K260425

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NUH 2026-03-04

TENS/EMS device (GUSE01)

Applicant Globalcare Medical Technology Co., Ltd.

K number K253896

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NUH 2025-12-31

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Applicant Shenzhen Jiantuo Electronics Co., Ltd.

K number K253305

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NUH 2025-12-23

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K number K253740

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NUH 2025-12-23

VEINOPLUS Back

Applicant Dynapulse Medical

K number K251958

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NUH 2025-11-24

Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

Applicant Bozhou Rongjian Medical Appliance Co., Ltd.

K number K252688

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NUH 2025-11-21

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

Applicant Everyway Medical Instruments Co.,Ltd

K number K251856

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NUH 2025-11-07

Triathlon Pro

Applicant Sigma Biomedical

K number K243131

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NUH 2025-08-28

OTC 4-Channel Rechargeable TENS Unit

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K number K251429

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NUH 2025-08-21

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)

Applicant Shenzhen Yicai Health Technology Co., Ltd.

K number K250784

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NUH 2025-07-28

3 in 1 TENS UNIT (TC1241, TC2241, TS1241)

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K number K251187

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NUH 2025-05-29

TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

Applicant Shenzhen Astec Technology Co., Ltd.

K number K243856

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NUH 2025-05-11

TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)

Applicant Shenzhen Jiantuo Electronics Co., Ltd.

K number K250360

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NUH 2025-05-09

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

Applicant Shenzhen Jiantuo Electronics Co., Ltd.

K number K250053

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NUH 2025-04-09

Patch-TEA (Model TRI-21)

Applicant Transtimulation Research, Inc.

K number K243613

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NUH 2025-04-07

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)

Applicant Guangzhou Pinzhi Medical Technology Co., Ltd.

K number K250033

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NUH 2025-04-02

Progenix Select Stim

Applicant Progenix, LLC

K number K242460

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NUH 2024-12-17

POCKET TENS (EP-300)

Applicant Hivox Biotek, Inc.

K number K242815

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NUH 2024-11-22

Nooro Body & Foot Stimulator (SM9141, SM9142)

Applicant Xf Agencija Limited

K number K243334

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NUH 2024-11-05

Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K242332

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NUH 2024-11-04

Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K number K242567

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NUH 2024-10-18

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator

Applicant Well-Life Healthcare Limited

K number K233054

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NUH 2024-09-09

TENS & EMS Stimulator (MHD-1083)

Applicant Shenzhen Minghuangda Electronics Co., Ltd.

K number K241678

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NUH 2024-08-12

Pixie Pulse (SM9068)

Applicant Pixie Cup, LLC

K number K241365

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NUH 2024-07-22

Transcutaneous Electrical Nerve Stimulator (K6106)

Applicant Shenzhen Yicai Health Technology Co., Ltd.

K number K241119

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NUH 2024-07-19

Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K number K233067

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NUH 2024-06-27

TENS&EMS units (SM9109A, SM9109B)

Applicant Plexus Yoga, LLC Dba Chirp

K number K241509

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NUH 2024-03-27

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K231425

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NUH 2024-03-25

Transcutaneous Electrical Nerve Stimulator (9029SCM)

Applicant Hong Kong Etech Groups Limited

K number K240292

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NUH 2024-03-21

Electrical Stimulator System

Applicant Gymmax Technology Shenzen Co., Ltd.

K number K232439

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NUH 2024-03-01

S21 OTC Transcutaneous Electrical Nerve Stimulator

Applicant Micro Current Technology, Inc.

K number K233095

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NUH 2024-03-01

Muscle Stimulator

Applicant Shenzhen Yiran Intelligent Co., Ltd.

K number K231648

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NUH 2024-02-23

ENSO (Model 2)

Applicant Hinge Health, Inc.

K number K233784

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NUH 2024-02-12

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K number K233092

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NUH 2024-02-12

EMS/TENS Massager Device

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K number K233040

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NUH 2024-01-22

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K number K231423

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NUH 2024-01-19

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

Applicant Hi-Dow International, Inc.

K number K233461

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NUH 2023-12-15

Ova+ (K-OVAP-USA)

Applicant Tenscare, Ltd.

K number K230926

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NUH 2023-12-08

Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K232517

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NUH 2023-11-03

ManaFlexx 2 (model: MF002-RX, MF002-OTC)

Applicant Manamed, Inc.

K number K231569

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NUH 2023-10-05

Heating Tens, FT-615

Applicant Hivox Biotek, Inc.

K number K232675

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NUH 2023-08-18

Unicare (K-UNICARE-USA)

Applicant Tenscare, Ltd.

K number K231053

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NUH 2023-07-19

Nu-beca Transcutaneous Electrical Nerve Stimulation

Applicant Nu-Beca & Maxcellent Co.

K number K223151

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NUH 2023-05-22

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Applicant Jiangxi Royall Smart Technology Co., Ltd.

K number K230443

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NUH 2023-05-13

HEATING TENS/EMS, FT-810R

Applicant Hivox Biotek, Inc.

K number K223308

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NUH 2023-05-10

Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K222870

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NUH 2023-05-09

Tens & Ems Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K number K223825

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NUH 2023-05-08

Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)

Applicant Shenzhen Leqing Medical Instrument Co., Ltd.

K number K223428

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NUH 2023-04-26

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K number K230829

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NUH 2023-04-10

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K number K230164

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NUH 2023-03-20

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K number K230174

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NUH 2023-03-20

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K number K230163

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NUH 2022-12-21

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

Applicant Andon Health Co, Ltd.

K number K222867

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NUH 2022-11-15

Everyway Analog OTC TENS

Applicant Everyway Medical Instruments Co.,Ltd

K number K222488

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NUH 2022-10-21

Electronic Pulse Stimulator

Applicant Beijing Choice Electronic Technology Co., Ltd.

K number K221992

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NUH 2022-09-13

Transcutaneous Electrical Nerve Stimulator Model: ST-304

Applicant Shenzhen Future Electronic Co., Ltd.

K number K221092

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NUH 2022-09-01

Wireless TENS/EMS, Bruno, Aela

Applicant Zmi Elecronics , Ltd.

K number K220997

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NUH 2022-08-24

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K220998

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NUH 2022-08-04

Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)

Applicant Well-Life Healthcare Limited

K number K220524

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NUH 2022-07-29

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

Applicant Guangzhou Huakai Electronic Technology Co., Ltd.

K number K221251

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NUH 2022-07-09

Noodle

Applicant Pourang Bral, Dds, LLC

K number K220573

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NUH 2022-06-11

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

Applicant Hivox Biotek, Inc.

K number K221384

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NUH 2022-05-06

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

Applicant Dongguan Bohuikang Technology Co.,Ltd

K number K213788

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NUH 2022-05-02

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K number K220283

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NUH 2022-04-19

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K number K220152

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NUH 2022-04-15

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01

Applicant Ningbo Medkinetic Medical Device Co., Ltd.

K number K212377

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NUH 2022-04-01

TENS & PMS Unit

Applicant Shenzhen Yuehua Xinsen Technology Co., Ltd.

K number K220005

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NUH 2022-04-01

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K number K212184

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NUH 2022-03-08

TENS & EMS DEVICE (Model: FM-B2403A)

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K number K213741

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NUH 2022-03-03

TENS & EMS Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K number K213835

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NUH 2022-02-19

Well-Life TENS/EMS/Heating Stimulator

Applicant Well-Life Healthcare Limited

K number K213091

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NUH 2022-02-17

TENS & PMS (Model: SM9126)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K number K220150

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NUH 2021-12-30

Intrelief

Applicant Easymed Instruments Co., Ltd.

K number K211263

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NUH 2021-12-22

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

Applicant Oriental Inspiration Limited

K number K212285

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NUH 2021-12-15

Transcutaneous Electrical Nerve Stimulator

Applicant Top-Rank Health Care Co., Ltd.

K number K210223

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NUH 2021-12-13

Heat StimPlus

Applicant Famidoc Technology Co., Ltd.

K number K212918

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NUH 2021-11-22

Low-frequency Stimulator (Model: AST-645, AST-646)

Applicant Shenzhen Osto Technology Co., Ltd.

K number K212989

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NUH 2021-11-12

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K number K202671

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NUH 2021-10-15

HIVOX OTC Electrical Stimulator, FT610-B

Applicant Hivox Biotek, Inc.

K number K211403

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NUH 2021-10-04

Smart Neck Stimulator

Applicant Guandong Skg Intelligent Technology Co., Ltd.

K number K200558

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NUH 2021-09-05

Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

Applicant Shenzhen Osto Technology Company Limited

K number K211736

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NUH 2021-06-11

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H

Applicant Shenzhen Osto Technology Company Limited

K number K210756

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NUH 2021-06-04

Perfect EMS

Applicant Tenscare, Ltd.

K number K200694

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NUH 2021-05-19

TENS & EMS Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K number K202866

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NUH 2021-03-25

Low-frequency Multi-function physiotherapy instrument

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K200177

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NUH 2021-03-10

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

Applicant Hivox Biotek, Inc.

K number K203574

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NUH 2020-12-22

Everyway Analog OTC TENS, model N103A/N302

Applicant Everyway Medical Instruments Co.,Ltd

K number K202849

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NUH 2020-11-25

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

Applicant Everyway Medical Instruments Co.,Ltd

K number K202470

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NUH 2020-11-13

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

Applicant Everyway Medical Instruments Co.,Ltd

K number K202317

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NUH 2020-10-24

Li-Battery powered OTC TENS/EMS Combination Stimulator

Applicant Everyway Medical Instruments Co.,Ltd

K number K201335

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NUH 2020-10-19

Transcutaneous Electronic Nerve Stimulator

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K200237

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NUH 2020-09-25

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K number K191982

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NUH 2020-09-04

MSLS6QF TENS/PMS Device

Applicant Self Doctor Care, LLC

K number K193655

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NUH 2020-08-12

Tyece OTC TENS Model

Applicant Tyece Limited

K number K200838

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NUH 2020-07-01

StimPlus Patch, StimPlus Patch, StimPlus Patch

Applicant Jkh Health Co., Ltd.

K number K200561

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NUH 2020-06-29

Electronic stimulator

Applicant Shenzhen Dongjilian Electronics Co., Ltd.

K number K200354

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NUH 2020-06-18

TENS and Muscle Stimulator

Applicant Shenzhen Astec Technology Co., Ltd.

K number K200727

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NUH 2020-06-12

Electrical Stimulator System

Applicant Gymmax Technology Shenzen Co., Ltd.

K number K192201

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