GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | GZJ |
|---|---|
| Device Name | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | actiTENS mini | Sublimed | Jan 16, 2026 | SESE |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | Aug 15, 2025 | SESE |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | Aug 30, 2024 | SESE |
| K241228 | TENSWave | Zynex Medical Officer | Aug 27, 2024 | SESE |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | Apr 19, 2024 | SESE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | Jan 24, 2023 | SESE |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | Sep 14, 2022 | SESE |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | Aug 26, 2022 | SESE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | May 25, 2022 | SESE |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | Apr 23, 2022 | SESE |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | Jun 18, 2021 | SESE |
| K202186 | TrueRelief Device | Truerelief | Mar 23, 2021 | SESE |
| K210202 | BioWaveGO RX | Biowave Corporation | Feb 24, 2021 | SESE |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | Dec 23, 2020 | SESE |
| K202159 | actiTENS | Sublimed | Dec 22, 2020 | SESE |
| K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | Nov 9, 2020 | SESE |
| K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | Aug 13, 2020 | SESE |
| K191547 | ReliefBand | Reliefband Technologies, LLC | Aug 30, 2019 | SESE |
| K182960 | ReliefBand | Reliefband Technologies, LLC | Jun 21, 2019 | SESE |
| K182025 | 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
