Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NUH — Predicate Candidate Screening
229 FDA 510(k) clearances under this product code; the 50 most recent screened below.
148 daysmedian FDA review time
333 days90th percentile
229clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | 2026-06-26 | 137 | 0 |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | 2026-06-16 | 126 | 0 |
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | 2026-03-04 | 89 | 0 |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, J | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-12-31 | 93 | 0 |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 2025-12-23 | 181 | 0 |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | 2025-12-23 | 29 | 0 |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2025-11-24 | 90 | 0 |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Mode | Everyway Medical Instruments Co.,Ltd | 2025-11-21 | 157 | 0 |
| K243131 | Triathlon Pro | Sigma Biomedical | 2025-11-07 | 403 | 0 |
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-08-28 | 112 | 0 |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K | Shenzhen Yicai Health Technology Co., Ltd. | 2025-08-21 | 160 | 0 |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-28 | 102 | 0 |
| K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS | Shenzhen Astec Technology Co., Ltd. | 2025-05-29 | 164 | 0 |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-11 | 90 | 0 |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-09 | 119 | 0 |
| K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | 2025-04-09 | 138 | 0 |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. | 2025-04-07 | 90 | 0 |
| K242460 | Progenix Select Stim | Progenix, LLC | 2025-04-02 | 226 | 0 |
| K242815 | POCKET TENS (EP-300) | Hivox Biotek, Inc. | 2024-12-17 | 90 | 0 |
| K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) | Xf Agencija Limited | 2024-11-22 | 29 | 0 |
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-23 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2024-11-05 | 90 | 0 |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and | Changsha Anxiang Medical Technology Co., Ltd. | 2024-11-04 | 67 | 0 |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator | Well-Life Healthcare Limited | 2024-10-18 | 389 | 0 |
| K241678 | TENS & EMS Stimulator (MHD-1083) | Shenzhen Minghuangda Electronics Co., Ltd. | 2024-09-09 | 90 | 0 |
| K241365 | Pixie Pulse (SM9068) | Pixie Cup, LLC | 2024-08-12 | 90 | 0 |
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd. | 2024-07-22 | 90 | 0 |
| K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-07-19 | 297 | 0 |
| K241509 | TENS&EMS units (SM9109A, SM9109B) | Plexus Yoga, LLC Dba Chirp | 2024-06-27 | 30 | 0 |
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2024-03-27 | 315 | 0 |
| K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) | Hong Kong Etech Groups Limited | 2024-03-25 | 53 | 0 |
| K232439 | Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. | 2024-03-21 | 220 | 0 |
| K233095 | S21 OTC Transcutaneous Electrical Nerve Stimulator | Micro Current Technology, Inc. | 2024-03-01 | 157 | 0 |
| K231648 | Muscle Stimulator | Shenzhen Yiran Intelligent Co., Ltd. | 2024-03-01 | 270 | 0 |
| K233784 | ENSO (Model 2) | Hinge Health, Inc. | 2024-02-23 | 88 | 0 |
| K233040 | EMS/TENS Massager Device | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-02-12 | 140 | 0 |
| K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-02-12 | 139 | 0 |
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C10 | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-22 | 250 | 0 |
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | Hi-Dow International, Inc. | 2024-01-19 | 88 | 0 |
| K230926 | Ova+ (K-OVAP-USA) | Tenscare, Ltd. | 2023-12-15 | 256 | 0 |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief ( | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-12-08 | 112 | 0 |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023-11-03 | 156 | 0 |
| K232675 | Heating Tens, FT-615 | Hivox Biotek, Inc. | 2023-10-05 | 34 | 0 |
| K231053 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023-08-18 | 127 | 0 |
| K223151 | Nu-beca Transcutaneous Electrical Nerve Stimulation | Nu-Beca & Maxcellent Co. | 2023-07-19 | 287 | 0 |
| K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. | 2023-05-22 | 90 | 0 |
| K223308 | HEATING TENS/EMS, FT-810R | Hivox Biotek, Inc. | 2023-05-13 | 197 | 0 |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-05-10 | 230 | 0 |
| K223825 | Tens & Ems Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2023-05-09 | 139 | 0 |
| K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLu | Shenzhen Leqing Medical Instrument Co., Ltd. | 2023-05-08 | 175 | 0 |
| K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2023-04-26 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda