FDA 510(k) Applications for Medical Device Product Code "NUH"
(Stimulator, Nerve, Transcutaneous, Over-The-Counter)

FDA 510(k) Number Applicant Device Name Decision Date
K133789 ACUMED MEDICAL LTD. DOLPHIN NEUROSTIM OTC 03/04/2015
K142686 AEMED, INC. StimPad OTC 12/18/2014
K222867 Andon Health Co., Ltd. AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) 12/21/2022
K150043 ANDON HEALTH CO.,LTD Transcutaneous Electrical Nerve Stimulators (TENS) 08/14/2015
K130150 ANHUI JINJIANQIAO MED-TECH CO,. LTD. TCM MASSAGER 09/26/2013
K162392 AVAZZIA, INC. Avazzia 05/12/2017
K171802 Bayer HealthCare LLC ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) 03/07/2018
K152852 BAYER HEALTHCARE, LLC ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) 12/22/2015
K221992 Beijing Choice Electronic Technology Co., Ltd. Electronic Pulse Stimulator 10/21/2022
K160508 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Electronic Pulse Stimulator 11/21/2016
K171026 Bewell Connect Corp. Mytens Model: BW-TSX 11/01/2017
K172971 BioMedical Life Systems, Inc. BMLS16-1 07/08/2018
K102051 BIOMEDICAL LIFE SYSTEMS, INC. PAIN BUDDY 07/29/2011
K230163 Changsha Yuwen Medical Equipment Co., Ltd TENS and EMS Stimulation (OTC) 03/20/2023
K230164 Changsha Yuwen Medical Equipment Co., Ltd TENS and EMS Stimulation (OTC) 04/10/2023
K230174 Changsha Yuwen Medical Equipment Co., Ltd TENS and EMS Stimulation (OTC) 03/20/2023
K212184 Changsha Yuwen Medical Equipment Co.,Ltd. TENS and EMS Stimulation (OTC) 04/01/2022
K131159 CHATTEM, INC. SMARTRELIEF 07/25/2013
K230829 Chongqing Rob Linka Science And Technology Co., Ltd. TENS7000 Rechargeable (Model:TENS7000 Rechargeable) 04/26/2023
K151279 COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD Counter OTC TENS Device, Model CSD-737Z 12/16/2015
K161537 COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD OTC TENS Device, Model PTS-IV 10/13/2016
K150277 COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD Pain Therapy System, Model PTS-II 02/12/2016
K132993 COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. COUNTER OTC TENS DEVICE 04/24/2014
K213788 Dongguan Bohuikang Technology Co.,Ltd TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) 05/06/2022
K143430 EASYMED INSTRUMENT CO., LTD. SmartTENS 05/29/2015
K140168 EASYMED INSTRUMENTS CO., LTD. EASYSTIM TN28_OTC 08/28/2014
K211263 EasyMed Instruments Co., Ltd. Intrelief 12/30/2021
K163166 EASYWELL BIOMEDICALS, INC. EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only 08/11/2017
K124055 ENDURANCE THERAPEUTICS T1040 AKA AURAWAVE 07/19/2013
K060846 ENDURANCE THERAPEUTICS THERAPEUTIC MASSAGE COMPANION 12/03/2007
K181207 Everyway Medical Instruments CO., LDT. Balego TENS Digital Edition with Accessories for Pain Relief (OTC) 06/06/2018
K181849 Everyway Medical Instruments CO., LDT. iStim S2 OTC Pain Relief TENS 08/10/2018
K222488 Everyway Medical Instruments Co., Ltd Everyway Analog OTC TENS 11/15/2022
K202849 Everyway Medical Instruments Co., Ltd Everyway Analog OTC TENS, model N103A/N302 12/22/2020
K201335 Everyway Medical Instruments Co., Ltd Li-Battery powered OTC TENS/EMS Combination Stimulator 10/24/2020
K182753 Everyway Medical Instruments Co., Ltd. A6 OTC Pain Relief TENS 10/26/2018
K172919 Everyway Medical Instruments Co., Ltd. EV-804 OTC Pain Relief TENS 04/19/2018
K151479 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. EV-820 OTC Pain Relief TENS 10/16/2015
K110716 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. EVERYWAY LOW BACK PAIN RELIEF SYSTEM 10/18/2011
K192589 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. Everyway OTC TENS/EMS Combination 12/19/2019
K181707 Everyway Medical Instruments Co., Ltd. Everyway Wireless TENS & EMS Unit 09/26/2018
K202470 Everyway Medical Instruments Co., Ltd. Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 11/25/2020
K202317 Everyway Medical Instruments Co., Ltd. Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 11/13/2020
K112415 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. LIFECARE ARM & LEG PAIN RELIEF SYSTEM 10/21/2011
K182767 Everyway Medical Instruments Co., Ltd. V2 OTC Pain Relief TENS 10/26/2018
K212918 Famidoc Technology Co., Ltd. Heat StimPlus 12/13/2021
K152374 Fuji Dynamics Ltd LL TENS 160A, LL TENS 160B 01/13/2016
K190988 Gemore Technology Co Ltd GIM-STIM OTC TENS/EMS System 08/16/2019
K150681 GEMORE TECHNOLOGY CO., LTD. GEMORE OTC TENS 05/12/2015
K060222 GEMORE TECHNOLOGY CO., LTD. LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP 04/28/2006
K200558 GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD Smart Neck Stimulator 10/04/2021
K221251 Guangzhou Hua Kai Electronic Technology Co., Ltd. Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) 07/29/2022
K182108 Guangzhou Longest Science & Technology Co., Ltd. Portable Electro-Stimulation Therapy Device 04/26/2019
K202671 Guangzhou Xinbo Electronic Co., Ltd. DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) 11/12/2021
K163611 Guangzhou Xinbo Electronic Co., Ltd. Pain Therapy Device 09/19/2017
K131933 GURIN PRODUCTS, LLC ELECTRONIC PULSE MASSAGER 12/20/2013
K192201 Gymmax Technology Shenzen Co., Ltd. Electrical Stimulator System 06/12/2020
K160255 HB MEDICAL, INC. HBOTC Muscle and Nerve Stimulator 09/15/2016
K131956 HEALTHCARE INNOVATIONS, LLC QUICK RELAX PRO 04/24/2014
K121757 HEALTHMATE INTERNATIONAL, LLC HEALTHMATEFOREVER 11/20/2012
K150308 HEAT IN A CLICK LLC Palm TENS 10/20/2015
K102598 HI-DOW INTERNATIONAL INC. HI-DOW-XP 05/13/2011
K163393 Hi-Dow International, Inc. Hi-Dow Wireless TENS/EMS System (Model HD-SN) 08/04/2017
K232675 Hivox Biotek Inc. Heating Tens, FT-615 10/05/2023
K221384 Hivox Biotek Inc. Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 06/11/2022
K223308 Hivox Biotek Inc. HEATING TENS/EMS, FT-810R 05/13/2023
K171803 Hivox Biotek Inc. HIVOX OTC Electrical Stimulator 11/29/2017
K190347 Hivox Biotek Inc. HIVOX OTC Electrical Stimulator 03/15/2019
K203574 Hivox Biotek Inc. HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 03/10/2021
K211403 Hivox Biotek Inc. HIVOX OTC Electrical Stimulator, FT610-B 10/15/2021
K112392 HIVOX BIOTEK, INC. HIVOX BIOTEK INC. 03/19/2012
K140650 HIVOX BIOTEK, INC. HIVOX ELECTRIC STIMULATOR OTC TENS 06/27/2014
K171599 Hollywog LLC WiTouch Pro, WiTouch, Neubac 09/22/2017
K120500 HOLLYWOG, LLC THE PAIN PILOT (A.K.A PAIN PILOT) 08/20/2012
K190009 Hong Qiangxing (Shen Zhen) Electronics Limited Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) 12/02/2019
K220150 Hong Qiangxing (Shen Zhen) Electronics Limited TENS & PMS (Model: SM9126) 02/17/2022
K220283 Hong Qiangxing (Shen Zhen) Electronics Limited TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) 05/02/2022
K220152 Hong Qiangxing (Shen Zhen) Electronics Limited TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) 04/19/2022
K100441 INTERNATIONAL TRADE GROUP, INC. XINIWAVE, MODEL XW-18 07/15/2010
K131290 IQ TECHNOLOGIES INC. IQ TECHNOLOGIES 08/06/2014
K170659 IQ Technologies Inc. IQ Technologies 05/26/2017
K230443 Jiangxi Royall Smart Technology Co., Ltd. TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) 05/22/2023
K200561 JKH Health Co., LTD StimPlus Patch, StimPlus Patch, StimPlus Patch 07/01/2020
K162517 JKH Health Co., Ltd. Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 04/14/2017
K153520 JKH HEALTH CO.,LTD. Electronic Pulse Stimulator 05/05/2016
K182203 JKH USA, LLC JKH Stimulator Plus 03/14/2019
K191151 JKH USA, LLC JKH Stimulator Plus 06/21/2019
K182671 JKH USA, LLC Medi-Direct TENS Pen 09/21/2019
K100116 LASER HEALTH TECHNOLOGIES, LLC LASERTOUCHONE (OTC) 04/15/2010
K163153 LIFECARE LTD. Livia 06/28/2017
K183110 LifeCare Ltd. LIVIA 05/04/2020
K160893 M.I.TECH CO.,LTD HANAROCare ReJu 07/27/2016
K131910 MARC PRO MPP 01/24/2014
K182267 Marchan Medical, LLC PAT (Pain Alleviation Technologies) 02/27/2019
K123866 MEDECELL US, INC TANYX 09/13/2013
K122410 MEDIRUNE CO, LTD I RUNE (I-200L) 11/12/2013
K162630 Mid-America Medical Innovations LLC CP Relief Wand-OTC 12/20/2016
K190115 MingHuangDa Electronic Co., Ltd MHD TENS 06/19/2019
K140333 NEUROMETRIX, INC. ASCEND 07/03/2014
K152954 NEUROMETRIX, INC. Quell 01/05/2016
K151995 NEWMARK, INC. Painmaster MCT Patch 10/05/2016
K130114 NEWMARK, INC. PAINMASTER MCT PATCH 04/16/2013
K090042 NEWMARK, INC. PAINMASTER MCT PATCH 05/06/2009
K212377 Ningbo MedKinetic Medical Device Co., Ltd. Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 04/15/2022
K223151 Nu-Beca & Maxcellent Co. Nu-beca Transcutaneous Electrical Nerve Stimulation 07/19/2023
K172079 Omron Healthcare, Inc. Avail 10/19/2017
K183215 Omron Healthcare, Inc. Focus TENS Therapy, Model PM710-M/-L 09/07/2019
K160115 OMRON HEALTHCARE, INC. Heat Pain Pro 06/03/2016
K181992 Omron Healthcare, Inc. Heat Pain Pro 11/09/2018
K182120 Omron Healthcare, Inc. Maxpower Relief 01/10/2019
K141978 OMRON HEALTHCARE, INC. MAXPOWER RELIEF 12/03/2014
K110068 OMRON HEALTHCARE, INC. MODEL PM3030 12/08/2011
K212285 Oriental Inspiration Limited Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) 12/22/2021
K062532 PAIN RELIEF TECHNOLOGIES ELECTROPULSE - LOW BACK PAIN 02/09/2007
K113037 PDI WORKS, LLC. PAIN-AID 03/01/2012
K181102 Pfizer Inc. ThermaCare Quick Therapy TENS 09/15/2018
K151035 PHILIPS CONSUMER LIFESTYLE PulseRelief 07/21/2015
K132563 PINOOK USA PINOOK STIMULATOR 04/24/2014
K182581 PlayMakar Inc. PlayMakar Sport Muscle Stimulator, Model PRO-500 11/21/2018
K220573 Pourang Bral, DDS, LLC Noodle 07/09/2022
K133502 PRIZM MEDICAL, INC. 5000Z FIREFLY SYSTEM 12/03/2014
K033122 PRIZM MEDICAL, INC. 5000Z SYSTEM (OTC) 08/25/2004
K122744 PROSPERA CORPORATION PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER 03/28/2013
K113321 SAVIA LIMITED TENS BACK PAIN RELIEF SYSTEM 09/04/2012
K193655 Self Doctor Care, LLC MSLS6QF TENS/PMS Device 09/04/2020
K200727 Shenzhen As Tec Technology Co., Ltd TENS and Muscle Stimulator 06/18/2020
K143268 SHENZHEN AS-TEC TECHNOLOGY CO., LTD TENS AND POWERED MUSCLE STIMULATOR 07/21/2015
K130802 SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) 09/16/2013
K110707 SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR 08/03/2011
K162479 SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. Smart Pain Reliever, Model LT5019 02/08/2017
K180331 Shenzhen Dongdixin Technology Co.,Ltd. Wireless Pain Relieve Device 06/22/2018
K173462 Shenzhen Dongdixin Technology Co.,Ltd. Wireless Pain Relieve Device Model: LT5018C 12/08/2017
K200354 Shenzhen Dongjilian Electronics Co.,Ltd. Electronic stimulator 06/29/2020
K170145 SHENZHEN EAPPLY TECHNOLOGY CO., LTD Digital TENS Unit 04/29/2017
K221092 Shenzhen Future Electronic Co., Ltd Transcutaneous Electrical Nerve Stimulator Model: ST-304 09/13/2022
K213835 Shenzhen Jian feng Electronic Technology Co. Ltd. TENS & EMS Device 03/03/2022
K223825 Shenzhen Jian Feng Electronic Technology Co., Ltd Tens & Ems Device 05/09/2023
K213741 Shenzhen Jianfeng Electronic Technology Co. Ltd. TENS & EMS DEVICE (Model: FM-B2403A) 03/08/2022
K202866 SHenzhen Jianfeng Electronic Technology Co., Ltd. TENS & EMS Device 05/19/2021
K131921 SHENZHEN JINGKEHUI ELECTRONIC CO., LTD ELECTRONIC PULSE STIMULATOR 11/15/2013
K141260 SHENZHEN JINGKEHUI ELECTRONIC CO., LTD ELECTRONIC PULSE STIMULATOR 09/17/2014
K150995 SHENZHEN JINGKEHUI ELECTRONIC CO., LTD Electronic Pulse Stimulator 07/06/2015
K182871 Shenzhen Jumper Medical Equipment Co., Ltd. Mini TENS Therapy Device 08/01/2019
K200177 Shenzhen Kentro Medical Electronics Co., Ltd Low-frequency Multi-function physiotherapy instrument 03/25/2021
K191982 Shenzhen Kentro Medical Electronics Co., Ltd 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) 09/25/2020
K170205 Shenzhen Kentro Medical Electronics Co., Ltd Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 05/11/2017
K183288 Shenzhen Kentro Medical Electronics Co., Ltd Transcutaneous Electrical Nerve Stimulator 07/30/2019
K222870 Shenzhen Kentro Medical Electronics Co., Ltd 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 05/10/2023
K200237 Shenzhen Kentro Medical Electronics Co., Ltd Transcutaneous Electronic Nerve Stimulator 10/19/2020
K220998 Shenzhen Kentro Medical Electronics Co., Ltd. Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 08/24/2022
K183674 Shenzhen Leading Perfection Technology Co., Ltd Electronic Pulse Stimulator 10/11/2019
K223428 Shenzhen Leqing Medical Instrument Co., Ltd 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) 05/08/2023
K172834 Shenzhen OSTO Technology Co., Ltd. Dual output digital therapy massager 09/06/2018
K182136 Shenzhen OSTO Technology Co., Ltd. Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) 10/10/2019
K172837 Shenzhen OSTO Technology Co., Ltd. Low-frequency Multi-function physiotherapy instrument 11/26/2018
K212989 Shenzhen OSTO Technology Co., Ltd. Low-frequency Stimulator (Model: AST-645, AST-646) 11/22/2021
K172897 Shenzhen OSTO Technology Co., Ltd. Neck Care Therapy, Model: SYK 509B 12/07/2018
K211736 Shenzhen OSTO Technology Company Limited Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) 09/05/2021
K133929 SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED HEALTH EXPERT ELCTRONIC STIMULATOR 11/12/2014
K190673 Shenzhen OSTO Technology Company Limited Health Expert Electronic Stimulator 12/12/2019
K190783 Shenzhen OSTO Technology Company Limited Health Expert Electronic Stimulator (model: AST-3000L) 03/14/2020
K210756 Shenzhen OSTO Technology Company Limited Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H 06/11/2021
K192087 Shenzhen Roundwhale Technology Co., Ltd. Combo Electrotherapy Device 11/01/2019
K180956 Shenzhen Roundwhale Technology Co., Ltd. Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator 06/07/2018
K220005 Shenzhen Yuehua Xinsen Technology Co., Ltd. TENS & PMS Unit 04/01/2022
K063743 SHOCKIM ENTERPRISES, LTD. RHYTHM TOUCH Q 2-WAY 05/24/2007
K172451 SmartMedicalDevice Co., Ltd. Dr.MUSIC 3s 11/17/2017
K133979 SUNMAS (H.K.) TRADING LIMITED TENS 08/26/2014
K231053 TensCare Ltd Unicare (K-UNICARE-USA) 08/18/2023
K200694 TensCare Ltd. Perfect EMS 06/04/2021
K160052 Thimble Bioelectronics, Inc. CUR Model 1 05/20/2016
K191075 TimeWaver Production GmbH Healy 11/22/2019
K152128 Tohkai Precision Electrical Manufactory (Shenzhen) Limited 2-in-1 Abdominal Muscle Training & Back Pain Relief System 12/23/2015
K210223 Top-Rank Health Care Co.,Ltd. Transcutaneous Electrical Nerve Stimulator 12/15/2021
K151034 TrioWave Technologies PainKARE 11/21/2015
K200838 Tyece Limited Tyece OTC TENS Model 08/12/2020
K150386 TYECE LTD Tyece OTC TENS Device 11/05/2015
K121353 WELL-LIFE HEALTHCARE LIMITED MINI PATCH 09/07/2012
K172809 Well-Life Healthcare Limited OTC Combo TENS/EMS System 10/18/2017
K141299 WELL-LIFE HEALTHCARE LIMITED OTC COMBO TENS/EMS SYSTEM 11/14/2014
K133723 WELL-LIFE HEALTHCARE LIMITED OTC PATCH 01/28/2014
K091757 WELL-LIFE HEALTHCARE LIMITED OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 02/05/2010
K052785 WELL-LIFE HEALTHCARE LIMITED OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 03/17/2006
K063660 WELL-LIFE HEALTHCARE LIMITED OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 02/07/2007
K161453 WELL-LIFE HEALTHCARE LIMITED WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A 12/05/2016
K220524 Well-Life Healthcare Limited Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) 08/04/2022
K213091 Well-Life Healthcare Limited Well-Life TENS/EMS/Heating Stimulator 02/19/2022
K220997 ZMI Elecronics Ltd. Wireless TENS/EMS, Bruno, Aela 09/01/2022


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