GZJ
- Product code
- GZJ
- Device name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5890
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 606 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252712 | 2026-05-28 | Algiamed Technologies USA, Inc. | STIMPOD NMS460 Nerve Stimulator | |
| K252767 | 2026-01-16 | Sublimed | actiTENS mini | |
| K252236 | 2025-08-15 | N & C Holdings, LLC | CP Relief Wand Rx - TENS/NMES | |
| K232441 | 2024-08-30 | Tenscare, Ltd. | Unipro (K-UNIPRO-US) | |
| K241228 | 2024-08-27 | Zynex Medical Officer | TENSWave | — |
| K233046 | 2024-04-19 | Oriental Inspiration Limited | Electrical Neuromuscular Stimulator, Cure Trio | — |
Official FDA classification page: GZJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).