Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) → GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief # GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief _Neurology · 21 CFR 882.5890 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ ## Overview - **Product Code:** GZJ - **Device Name:** Stimulator, Nerve, Transcutaneous, For Pain Relief - **Regulation:** [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 605) Showing 20 most recent of 605 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252767](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K252767.md) | actiTENS mini | Sublimed | Jan 16, 2026 | SESE | | [K252236](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K252236.md) | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | Aug 15, 2025 | SESE | | [K232441](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K232441.md) | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | Aug 30, 2024 | SESE | | [K241228](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K241228.md) | TENSWave | Zynex Medical Officer | Aug 27, 2024 | SESE | | [K233046](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K233046.md) | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | Apr 19, 2024 | SESE | | [K222879](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K222879.md) | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | Jan 24, 2023 | SESE | | [K212618](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K212618.md) | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | Sep 14, 2022 | SESE | | [K213802](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K213802.md) | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | Aug 26, 2022 | SESE | | [K220578](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K220578.md) | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | May 25, 2022 | SESE | | [K220503](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K220503.md) | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | Apr 23, 2022 | SESE | | [K202893](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K202893.md) | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | Jun 18, 2021 | SESE | | [K202186](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K202186.md) | TrueRelief Device | Truerelief | Mar 23, 2021 | SESE | | [K210202](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K210202.md) | BioWaveGO RX | Biowave Corporation | Feb 24, 2021 | SESE | | [K201458](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K201458.md) | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | Dec 23, 2020 | SESE | | [K202159](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K202159.md) | actiTENS | Sublimed | Dec 22, 2020 | SESE | | [K201431](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K201431.md) | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | Nov 9, 2020 | SESE | | [K181645](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K181645.md) | StimaWELL 120MTRS | Pierenkemper GmbH | Aug 13, 2020 | SESE | | [K191547](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K191547.md) | ReliefBand | Reliefband Technologies, LLC | Aug 30, 2019 | SESE | | [K182960](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K182960.md) | ReliefBand | Reliefband Technologies, LLC | Jun 21, 2019 | SESE | | [K182025](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K182025.md) | ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. | Jan 2, 2019 | SESE | ## Top Applicants - Biomedical Life Systems, Inc. — 20 clearances - Empi — 17 clearances - Medical Devices, Inc. — 16 clearances - American Imex — 11 clearances - Bio-Medical Research, Ltd. — 10 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com