Atlas FDA

NUH

229 FDA 510(k) clearances · Product code

148 daysmedian time to decision
333 days90th percentile
229clearances measured

FDA profile

Official device name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Medical specialty
Neurology
Flags
Third-party review eligible
FDA definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Adverse events (MAUDE)
2014: 9 · 2015: 11 · 2016: 13 · 2017: 21 · 2018: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TENS 7000 Rechargeable 4 Channel (TENS 7000H) (K260412)Shenzhen Dongdixin Technology Co., Ltd.2026-06-26
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) (K260425)Hivox Biotek, Inc.2026-06-16
TENS/EMS device (GUSE01) (K253896)Globalcare Medical Technology Co., Ltd.2026-03-04
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (K253305)Shenzhen Jiantuo Electronics Co., Ltd.2025-12-31
VEINOPLUS Back (K251958)Dynapulse Medical2025-12-23
TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (K253740)Hong Qiangxing (Shenzhen) Electronics Limited2025-12-23
Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (K252688)Bozhou Rongjian Medical Appliance Co., Ltd.2025-11-24
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (K251856)Everyway Medical Instruments Co.,Ltd2025-11-21
Triathlon Pro (K243131)Sigma Biomedical2025-11-07
OTC 4-Channel Rechargeable TENS Unit (K251429)Changsha Anxiang Medical Technology Co., Ltd.2025-08-28
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) (K250784)Shenzhen Yicai Health Technology Co., Ltd.2025-08-21
3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (K251187)Changsha Anxiang Medical Technology Co., Ltd.2025-07-28
TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (K243856)Shenzhen Astec Technology Co., Ltd.2025-05-29
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) (K250360)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-11
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) (K250053)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-09
Patch-TEA (Model TRI-21) (K243613)Transtimulation Research, Inc.2025-04-09
Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) (K250033)Guangzhou Pinzhi Medical Technology Co., Ltd.2025-04-07
Progenix Select Stim (K242460)Progenix, LLC2025-04-02
POCKET TENS (EP-300) (K242815)Hivox Biotek, Inc.2024-12-17
Nooro Body & Foot Stimulator (SM9141, SM9142) (K243334)Xf Agencija Limited2024-11-22
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) (K242332)Shenzhen Kentro Medical Electronics Co., Ltd.2024-11-05
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) (K242567)Changsha Anxiang Medical Technology Co., Ltd.2024-11-04
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (K233054)Well-Life Healthcare Limited2024-10-18
TENS & EMS Stimulator (MHD-1083) (K241678)Shenzhen Minghuangda Electronics Co., Ltd.2024-09-09
Pixie Pulse (SM9068) (K241365)Pixie Cup, LLC2024-08-12
Transcutaneous Electrical Nerve Stimulator (K6106) (K241119)Shenzhen Yicai Health Technology Co., Ltd.2024-07-22
Wireless TENS & EMS (Model SM9110,SM9113,SM9116) (K233067)Chongqing Rob Linka Science and Technology Co., Ltd.2024-07-19
TENS&EMS units (SM9109A, SM9109B) (K241509)Plexus Yoga, LLC Dba Chirp2024-06-27
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (K231425)Wuxi Jiajian Medical Instrument Co., Ltd.2024-03-27
Transcutaneous Electrical Nerve Stimulator (9029SCM) (K240292)Hong Kong Etech Groups Limited2024-03-25
Electrical Stimulator System (K232439)Gymmax Technology Shenzen Co., Ltd.2024-03-21
S21 OTC Transcutaneous Electrical Nerve Stimulator (K233095)Micro Current Technology, Inc.2024-03-01
Muscle Stimulator (K231648)Shenzhen Yiran Intelligent Co., Ltd.2024-03-01
ENSO (Model 2) (K233784)Hinge Health, Inc.2024-02-23
EMS/TENS Massager Device (K233040)Shenzhen Imdk Medical Technology Co., Ltd.2024-02-12
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) (K233092)Chongqing Rob Linka Science and Technology Co., Ltd.2024-02-12
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) (K231423)Shenzhen Roundwhale Technology Co. , Ltd.2024-01-22
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) (K233461)Hi-Dow International, Inc.2024-01-19
Ova+ (K-OVAP-USA) (K230926)Tenscare, Ltd.2023-12-15
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) (K232517)Shenzhen Kentro Medical Electronics Co., Ltd.2023-12-08
ManaFlexx 2 (model: MF002-RX, MF002-OTC) (K231569)Manamed, Inc.2023-11-03
Heating Tens, FT-615 (K232675)Hivox Biotek, Inc.2023-10-05
Unicare (K-UNICARE-USA) (K231053)Tenscare, Ltd.2023-08-18
Nu-beca Transcutaneous Electrical Nerve Stimulation (K223151)Nu-Beca & Maxcellent Co.2023-07-19
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) (K230443)Jiangxi Royall Smart Technology Co., Ltd.2023-05-22
HEATING TENS/EMS, FT-810R (K223308)Hivox Biotek, Inc.2023-05-13
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 (K222870)Shenzhen Kentro Medical Electronics Co., Ltd.2023-05-10
Tens & Ems Device (K223825)Shenzhen Jian Feng Electronic Technology Co., Ltd.2023-05-09
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) (K223428)Shenzhen Leqing Medical Instrument Co., Ltd.2023-05-08
TENS7000 Rechargeable (Model:TENS7000 Rechargeable) (K230829)Chongqing Rob Linka Science and Technology Co., Ltd.2023-04-26
TENS and EMS Stimulation (OTC) (K230164)Changsha Yuwen Medical Equipment Co., Ltd.2023-04-10
TENS and EMS Stimulation (OTC) (K230163)Changsha Yuwen Medical Equipment Co., Ltd.2023-03-20
TENS and EMS Stimulation (OTC) (K230174)Changsha Yuwen Medical Equipment Co., Ltd.2023-03-20
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (K222867)Andon Health Co, Ltd.2022-12-21
Everyway Analog OTC TENS (K222488)Everyway Medical Instruments Co.,Ltd2022-11-15
Electronic Pulse Stimulator (K221992)Beijing Choice Electronic Technology Co., Ltd.2022-10-21
Transcutaneous Electrical Nerve Stimulator Model: ST-304 (K221092)Shenzhen Future Electronic Co., Ltd.2022-09-13
Wireless TENS/EMS, Bruno, Aela (K220997)Zmi Elecronics , Ltd.2022-09-01
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (K220998)Shenzhen Kentro Medical Electronics Co., Ltd.2022-08-24
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) (K220524)Well-Life Healthcare Limited2022-08-04
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) (K221251)Guangzhou Huakai Electronic Technology Co., Ltd.2022-07-29
Noodle (K220573)Pourang Bral, Dds, LLC2022-07-09
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 (K221384)Hivox Biotek, Inc.2022-06-11
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) (K213788)Dongguan Bohuikang Technology Co.,Ltd2022-05-06
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) (K220283)Hong Qiangxing (Shenzhen) Electronics Limited2022-05-02
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) (K220152)Hong Qiangxing (Shenzhen) Electronics Limited2022-04-19
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 (K212377)Ningbo Medkinetic Medical Device Co., Ltd.2022-04-15
TENS and EMS Stimulation (OTC) (K212184)Changsha Yuwen Medical Equipment Co., Ltd.2022-04-01
TENS & PMS Unit (K220005)Shenzhen Yuehua Xinsen Technology Co., Ltd.2022-04-01
TENS & EMS DEVICE (Model: FM-B2403A) (K213741)Shenzhen Jian Feng Electronic Technology Co., Ltd.2022-03-08
TENS & EMS Device (K213835)Shenzhen Jian Feng Electronic Technology Co., Ltd.2022-03-03
Well-Life TENS/EMS/Heating Stimulator (K213091)Well-Life Healthcare Limited2022-02-19
TENS & PMS (Model: SM9126) (K220150)Hong Qiangxing (Shenzhen) Electronics Limited2022-02-17
Intrelief (K211263)Easymed Instruments Co., Ltd.2021-12-30
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) (K212285)Oriental Inspiration Limited2021-12-22
Transcutaneous Electrical Nerve Stimulator (K210223)Top-Rank Health Care Co., Ltd.2021-12-15
Heat StimPlus (K212918)Famidoc Technology Co., Ltd.2021-12-13
Low-frequency Stimulator (Model: AST-645, AST-646) (K212989)Shenzhen Osto Technology Co., Ltd.2021-11-22
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) (K202671)Guangzhou Xinbo Electronic Co., Ltd.2021-11-12
HIVOX OTC Electrical Stimulator, FT610-B (K211403)Hivox Biotek, Inc.2021-10-15
Smart Neck Stimulator (K200558)Guandong Skg Intelligent Technology Co., Ltd.2021-10-04
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) (K211736)Shenzhen Osto Technology Company Limited2021-09-05
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (K210756)Shenzhen Osto Technology Company Limited2021-06-11
Perfect EMS (K200694)Tenscare, Ltd.2021-06-04
TENS & EMS Device (K202866)Shenzhen Jian Feng Electronic Technology Co., Ltd.2021-05-19
Low-frequency Multi-function physiotherapy instrument (K200177)Shenzhen Kentro Medical Electronics Co., Ltd.2021-03-25
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (K203574)Hivox Biotek, Inc.2021-03-10
Everyway Analog OTC TENS, model N103A/N302 (K202849)Everyway Medical Instruments Co.,Ltd2020-12-22
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 (K202470)Everyway Medical Instruments Co.,Ltd2020-11-25
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 (K202317)Everyway Medical Instruments Co.,Ltd2020-11-13
Li-Battery powered OTC TENS/EMS Combination Stimulator (K201335)Everyway Medical Instruments Co.,Ltd2020-10-24
Transcutaneous Electronic Nerve Stimulator (K200237)Shenzhen Kentro Medical Electronics Co., Ltd.2020-10-19
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) (K191982)Shenzhen Kentro Medical Electronics Co., Ltd.2020-09-25
MSLS6QF TENS/PMS Device (K193655)Self Doctor Care, LLC2020-09-04
Tyece OTC TENS Model (K200838)Tyece Limited2020-08-12
StimPlus Patch, StimPlus Patch, StimPlus Patch (K200561)Jkh Health Co., Ltd.2020-07-01
Electronic stimulator (K200354)Shenzhen Dongjilian Electronics Co., Ltd.2020-06-29
TENS and Muscle Stimulator (K200727)Shenzhen Astec Technology Co., Ltd.2020-06-18
Electrical Stimulator System (K192201)Gymmax Technology Shenzen Co., Ltd.2020-06-12
LIVIA (K183110)Lifecare , Ltd.2020-05-04
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