Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NGX — Predicate Candidate Screening
162 FDA 510(k) clearances under this product code; the 50 most recent screened below.
174 daysmedian FDA review time
385 days90th percentile
162clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 | 123 | 0 |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026-03-12 | 113 | 0 |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026-01-16 | 108 | 0 |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 | 153 | 0 |
| K253478 | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | 2025-11-06 | 23 | 0 |
| K251594 | truFlex | Syrma Johari Medtech Limited | 2025-08-28 | 93 | 0 |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 | 57 | 0 |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025-07-14 | 73 | 0 |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025-07-02 | 26 | 0 |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 | 92 | 0 |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025-05-30 | 248 | 0 |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 | 131 | 0 |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa Srl | 2025-05-15 | 227 | 0 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025-04-18 | 87 | 0 |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 | 96 | 0 |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2025-02-25 | 266 | 0 |
| K243511 | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-02-10 | 90 | 0 |
| K233770 | Pepper EMS Training System | Pepper Interactive, Inc. | 2025-01-16 | 419 | 0 |
| K242787 | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-12-18 | 93 | 0 |
| K232982 | EMS Sculpt Machine | Shandong Huamei Technology Co., Ltd. | 2024-11-25 | 430 | 0 |
| K242186 | Neo Sculptor (OF-NEO001) | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | 2024-09-17 | 54 | 0 |
| K241685 | SofWave System | Sofwave Medical, Ltd. | 2024-08-07 | 57 | 0 |
| K240347 | PTG-05 | Zimmer Medizinsysteme GmbH | 2024-07-21 | 167 | 0 |
| K230711 | Pain Therapy Device(Model: P.T.S-X) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-05-16 | 428 | 0 |
| K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS | Hebei JT Medical Co., Ltd. | 2024-04-24 | 275 | 0 |
| K232409 | Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2024-04-10 | 244 | 0 |
| K233070 | Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566, | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-03-13 | 169 | 0 |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-03-11 | 265 | 0 |
| K222400 | Coresculpt & Magsculpt | K1Med Co., Ltd. | 2024-02-27 | 567 | 0 |
| K233035 | Electronic Muscle Stimulator (Model MP01) | Shenzhen Hengbosi Industrial Co., Ltd. | 2024-01-08 | 105 | 0 |
| K233492 | EMS Neck Massager | Xiamen Comfier Technology Co., Ltd. | 2023-12-20 | 51 | 0 |
| K233470 | DEKA LILY | El.En S.P.A. | 2023-12-19 | 55 | 0 |
| K230024 | HI-EMT MAGSHAPE | Beijing Sano Laser S&T Development Co.,Ltd | 2023-09-06 | 245 | 0 |
| K220938 | Nova HD+ | Aura Wellness, LLC | 2023-08-22 | 509 | 0 |
| K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Te | Beijing Adss Development Co., Ltd. | 2023-07-07 | 60 | 0 |
| K231136 | Fitness Belt (Model: KLT-07) | Shenzhen Kelutongda Industrial Co., Ltd. | 2023-06-16 | 56 | 0 |
| K231368 | Bemer Therapy System Evo | Bemer Int AG | 2023-06-09 | 29 | 0 |
| K230261 | Gnesis EMS Plus | Creative Fitness Developments S.L. | 2023-06-06 | 126 | 0 |
| K222875 | Powered Muscle Stimulator (Model name:MagGraver F200) | Nanjing Vishee Medical Technology Co., Ltd. | 2023-03-09 | 168 | 0 |
| K222386 | Visionbody | Vb Technologies AG | 2023-02-24 | 200 | 0 |
| K223797 | Neuro20 Pro System | Neuro20 Technologies | 2023-02-23 | 66 | 0 |
| K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023-01-31 | 280 | 0 |
| K212866 | truSculpt flex | Johari Digital Healthcare Limited | 2022-12-03 | 451 | 0 |
| K213748 | CoreLevee | Lutronic Corporation | 2022-10-14 | 318 | 0 |
| K221498 | Miha Bodytec II | Miha Bodytec GmbH | 2022-10-07 | 137 | 0 |
| K211298 | WiEMSpro | Medical Cables S.L. | 2022-08-25 | 484 | 0 |
| K212413 | I-Motion | I-Motion Group Global Iberica S.L. | 2022-05-26 | 296 | 0 |
| K220601 | CoolTone | Zimmer Medizinsysteme GmbH | 2022-04-01 | 30 | 0 |
| K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy , Ltd. | 2021-12-17 | 273 | 0 |
| K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AS | Shenzhen Osto Technology Company Limited | 2021-12-13 | 173 | 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