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 |
| K242567 | Changsha Anxiang Medical Technology Co., Ltd. | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | 11/04/2024 |
| 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 |
| K233092 | Chongqing Rob Linka Science and Technology Co., Ltd. | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | 02/12/2024 |
| K230829 | Chongqing Rob Linka Science And Technology Co., Ltd. | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) | 04/26/2023 |
| K233067 | Chongqing Rob Linka Science And Technology Co., Ltd. | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | 07/19/2024 |
| 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 |
| K250033 | Guangzhou Pinzhi Medical Technology Co., LTD | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | 04/07/2025 |
| 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 |
| K232439 | Gymmax Technology Shenzen Co., Ltd. | Electrical Stimulator System | 03/21/2024 |
| 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 |
| K233461 | Hi-Dow International, Inc. | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | 01/19/2024 |
| K163393 | Hi-Dow International, Inc. | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | 08/04/2017 |
| K233784 | Hinge Health, Inc. | ENSO (Model 2) | 02/23/2024 |
| 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 |
| K242815 | HIVOX BIOTEK INC. | POCKET TENS (EP-300) | 12/17/2024 |
| 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 |
| K240292 | Hong Kong Etech Groups Limited | Transcutaneous Electrical Nerve Stimulator (9029SCM) | 03/25/2024 |
| 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 |
| K231569 | ManaMed, Inc | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | 11/03/2023 |
| 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 |
| K233095 | Micro Current Technology, Inc. | S21 OTC Transcutaneous Electrical Nerve Stimulator | 03/01/2024 |
| 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 |
| K241365 | Pixie Cup LLC | Pixie Pulse (SM9068) | 08/12/2024 |
| K182581 | PlayMakar Inc. | PlayMakar Sport Muscle Stimulator, Model PRO-500 | 11/21/2018 |
| K241509 | Plexus Yoga LLC Dba Chirp | TENS&EMS units (SM9109A, SM9109B) | 06/27/2024 |
| 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 |
| K242460 | Progenix LLC | Progenix Select Stim | 04/02/2025 |
| 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 |
| K243856 | Shenzhen AsTec Technology Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | 05/29/2025 |
| 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 |
| K233040 | Shenzhen IMDK Medical Technology Co., Ltd. | EMS/TENS Massager Device | 02/12/2024 |
| 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 |
| K250053 | Shenzhen Jiantuo Electronics Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | 05/09/2025 |
| K250360 | Shenzhen Jiantuo Electronics Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | 05/11/2025 |
| 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 |
| K232517 | Shenzhen Kentro Medical Electronics Co., Ltd. | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | 12/08/2023 |
| K220998 | Shenzhen Kentro Medical Electronics Co., Ltd. | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | 08/24/2022 |
| K242332 | Shenzhen Kentro Medical Electronics Co., Ltd. | 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) | 11/05/2024 |
| 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 |
| K241678 | Shenzhen Minghuangda Electronics Co., Ltd. | TENS & EMS Stimulator (MHD-1083) | 09/09/2024 |
| 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-300L) | 03/14/2020 |
| K210756 | Shenzhen OSTO Technology Company Limited | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | 06/11/2021 |
| K231423 | Shenzhen Roundwhale Technology Co. Ltd. | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | 01/22/2024 |
| 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 |
| K241119 | Shenzhen Yicai Health Technology Co., Ltd. | Transcutaneous Electrical Nerve Stimulator (K6106) | 07/22/2024 |
| K231648 | Shenzhen Yiran Intelligent Co., Ltd | Muscle Stimulator | 03/01/2024 |
| 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 |
| K230926 | TensCare Ltd | Ova+ (K-OVAP-USA) | 12/15/2023 |
| 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 |
| K243613 | Transtimulation Research, Inc | Patch-TEA (Model TRI-21) | 04/09/2025 |
| 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 |
| K233054 | Well-Life Healthcare Limited | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | 10/18/2024 |
| K213091 | Well-Life Healthcare Limited | Well-Life TENS/EMS/Heating Stimulator | 02/19/2022 |
| K231425 | Wuxi Jiajian Medical Instrument Co., Ltd | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | 03/27/2024 |
| K243334 | XF Agencija Limited | Nooro Body & Foot Stimulator (SM9141, SM9142) | 11/22/2024 |
| K220997 | ZMI Elecronics Ltd. | Wireless TENS/EMS, Bruno, Aela | 09/01/2022 |
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