Product code GZJ
- Device name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5890
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252767 | actiTENS mini | Sublimed | 2026-01-16 |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025-08-15 |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024-08-30 |
| K241228 | TENSWave | Zynex Medical Officer | 2024-08-27 |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | 2024-04-19 |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | 2022-09-14 |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022-08-26 |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | 2022-04-23 |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 |
| K202186 | TrueRelief Device | Truerelief | 2021-03-23 |
| K210202 | BioWaveGO RX | Biowave Corporation | 2021-02-24 |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020-12-23 |
| K202159 | actiTENS | Sublimed | 2020-12-22 |
| K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | 2020-11-09 |
| K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | 2020-08-13 |
| K191547 | ReliefBand | Reliefband Technologies, LLC | 2019-08-30 |
| K182960 | ReliefBand | Reliefband Technologies, LLC | 2019-06-21 |
| K182025 | ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. | 2019-01-02 |
| K180943 | BioWaveGO | Biowave Corporation | 2018-08-17 |
| K172478 | TENS device-EmeTerm, CinvStop | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-04-19 |
| K173233 | ReliefBand 1.5 | Reliefband Technologies | 2017-11-30 |
| K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017-01-18 |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | Well-Life Healthcare Limited | 2017-01-17 |
| K160246 | SimulCare II(TM) | Xanacare Technologies, LLC | 2016-10-06 |
| K153704 | Strive | Djo, LLC | 2016-06-03 |
| K152676 | FD TENS 2090, FD TENS 2095 | Fuji Dynamics , Ltd. | 2016-01-22 |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Biowave Corporation | 2015-09-25 |
| K143198 | Synapse Transcutaneous Electrical Stimulation Device | Synapse Electroceutical Limited | 2015-05-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850298007072 | Monitoring Lead Wires, Set of 9 | SOMATICS, LLC | 2026-05-28 |
| 03770018808086 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808093 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808109 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808116 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808253 | actiTENS Mini | SUBLIMED | 2026-05-27 |
| 03770018808260 | actiTENS Mini | SUBLIMED | 2026-05-27 |
| 08809851470091 | EVE Synergy; EVE Titan | WEERO Co., Ltd. | 2025-06-24 |
| M368GFDF51 | GRAFCO | GF HEALTH PRODUCTS, INC. | 2019-09-06 |
| 08055765540003 | FREMSLIFE | FREMSLIFE SRL | 2018-01-28 |
| 07898961579030 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579047 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579054 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579108 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579115 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579023 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579016 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-03-17 |
| M220P641002 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| M220P6420002 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 10660584000116 | Dynatron 25 Series 825B | Dynatronics Corporation | 2016-09-24 |
| 10660584000055 | Dynatron Solaris Plus 705 | Dynatronics Corporation | 2016-09-24 |
| 10660584000048 | Dynatron Solaris Plus 706 | Dynatronics Corporation | 2016-09-24 |
| 10660584000031 | Dynatron Solaris Plus 707 | Dynatronics Corporation | 2016-09-24 |
| 10660584000024 | Dynatron Solaris Plus 708 | Dynatronics Corporation | 2016-09-24 |
| 10660584000017 | Dynatron Solaris Plus 709 | Dynatronics Corporation | 2016-09-24 |
| M368SW10001 | LUMISCOPE | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| M368LUMITENS1 | LUMISCOPE | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| M368GFTX51 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| M368GF3T1 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| M368GF31 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |