FDA product code GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief
GZJ is the FDA product code for stimulator, nerve, transcutaneous, for pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 606 510(k) submissions under GZJ, 11 in the last five years, from 324 different applicants. The average 510(k) review took 150 days (median 112); 157 days on average over the last three years. FDA has posted 7 recalls for GZJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GZJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 148 |
| 2018 | 2 | 188 |
| 2019 | 3 | 158 |
| 2020 | 4 | 322 |
| 2021 | 3 | 175 |
| 2022 | 4 | 200 |
| 2023 | 1 | 124 |
| 2024 | 3 | 235 |
| 2025 | 1 | 29 |
| 2026 | 2 | 207 |
Compare with all 510(k) review times · Search every GZJ clearance
Top GZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomedical Life Systems, Inc. | 20 | 2006-07-26 |
| Empi | 17 | 2009-06-05 |
| Medical Devices, Inc. | 16 | 1994-03-14 |
| American Imex | 11 | 2004-01-07 |
| Bio-Medical Research, Ltd. | 10 | 2012-01-09 |
319 more applicants have GZJ clearances. See the full list in Caduvo.
Most recent GZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252712 | Algiamed Technologies USA, Inc. | STIMPOD NMS460 Nerve Stimulator | 2026-05-28 | 274 |
| K252767 | Sublimed | actiTENS mini | 2026-01-16 | 140 |
| K252236 | N & C Holdings, LLC | CP Relief Wand Rx - TENS/NMES | 2025-08-15 | 29 |
| K232441 | Tenscare, Ltd. | Unipro (K-UNIPRO-US) | 2024-08-30 | 382 |
| K241228 | Zynex Medical Officer | TENSWave | 2024-08-27 | 117 |
Recalls for GZJ devices
7 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-02-07.
Frequently asked questions
What is FDA product code GZJ?
GZJ is the FDA product code for stimulator, nerve, transcutaneous, for pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is GZJ?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZJ?
Across 606 cleared submissions the average was 150 days from receipt to decision (median 112).
Which companies have the most GZJ clearances?
Biomedical Life Systems, Inc. (20); Empi (17); Medical Devices, Inc. (16); American Imex (11); Bio-Medical Research, Ltd. (10).
Have GZJ devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2011-02-07.
Next steps
- Run an FDA pathway report with predicate devices for product code GZJ
- Run a recall and safety report across every GZJ manufacturer
- Watch product code GZJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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