Product code GZJ: 510(k) clearances and predicates
Product code GZJ covers STIMPOD NMS460 Nerve Stimulator. FDA lists 606 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
606 clearances on file under product code GZJ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 so far | 2 |
Recent clearances
Newest GZJ clearances in the FDA index, with applicant and decision date:
- K252712, STIMPOD NMS460 Nerve Stimulator, applicant Algiamed Technologies USA, Inc., decided 2026-05-28. FDA record
- K252767, actiTENS mini, applicant Sublimed, decided 2026-01-16. FDA record
- K252236, CP Relief Wand Rx - TENS/NMES, applicant N & C Holdings, LLC, decided 2025-08-15. FDA record
- K232441, Unipro (K-UNIPRO-US), applicant Tenscare, Ltd., decided 2024-08-30. FDA record
- K241228, TENSWave, applicant Zynex Medical Officer, decided 2024-08-27. FDA record
- K233046, Electrical Neuromuscular Stimulator, Cure Trio, applicant Oriental Inspiration Limited, decided 2024-04-19. FDA record
- K222879, Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1), applicant Wuxi Jiajian Medical Instrument Co., Ltd., decided 2023-01-24. FDA record
- K212618, iRelieve Microcurrent Pain Relief System, applicant Fast Track Technologies, Inc., decided 2022-09-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include actiTENS mini, CP Relief Wand Rx - TENS/NMES. Watch new GZJ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code GZJ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent GZJ clearances include STIMPOD NMS460 Nerve Stimulator.
How many 510(k) clearances use product code GZJ?
606 at the time this page was generated, from openFDA records.
How do I find a predicate device under GZJ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new GZJ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.