GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief Class II
FDA product code GZJ covers "Stimulator, Nerve, Transcutaneous, For Pain Relief", a Class II medical device regulated under 21 CFR 882.5890. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GZJ
- Device Class
- Class II
- Regulation Number
- 882.5890
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252712 | algiamed technologies usa | STIMPOD NMS460 Nerve Stimulator | May 28, 2026 |
| K252767 | sublimed | actiTENS mini | January 16, 2026 |
| K252236 | n and c holdings | CP Relief Wand Rx - TENS/NMES | August 15, 2025 |
| K232441 | tenscare | Unipro (K-UNIPRO-US) | August 30, 2024 |
| K241228 | zynex medical officer | TENSWave | August 27, 2024 |
| K233046 | oriental inspiration limited | Electrical Neuromuscular Stimulator, Cure Trio | April 19, 2024 |
| K222879 | wuxi jiajian medical instrument co | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | January 24, 2023 |
| K212618 | fast track technologies | iRelieve Microcurrent Pain Relief System | September 14, 2022 |
| K213802 | gimer medical co | StimOnTM Pain Relief System (GM2439) | August 26, 2022 |
| K220578 | bozhou rongjian medical appliance co | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | May 25, 2022 |
| K220503 | wat medical technology | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | April 23, 2022 |
| K202893 | wuxi jiajian medical instrument co | Transcutaneous Electrical Nerve Stimulator | June 18, 2021 |
| K202186 | truerelief | TrueRelief Device | March 23, 2021 |
| K210202 | biowave corporation | BioWaveGO RX | February 24, 2021 |
| K201458 | delta international services and logistics | Scrambler Therapy Technology (Model ST-5A) | December 23, 2020 |
| K202159 | sublimed | actiTENS | December 22, 2020 |
| K201431 | gongguan tutamen metalwork co | OGYILI TENS/NMES Stimulator | November 9, 2020 |
| K181645 | pierenkemper | StimaWELL 120MTRS | August 13, 2020 |
| K191547 | reliefband technologies | ReliefBand | August 30, 2019 |
| K182960 | reliefband technologies | ReliefBand | June 21, 2019 |