FDA product code · Neurology
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
Product code GZJ covers Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II device regulated under 21 CFR 882.5890. FDA has cleared 606 devices in this code, 3 of them in the last 12 months. Median review time across the 606 most recent decisions is 112 days. openFDA lists 7 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.5890
- Review panel
- Neurology
- Clearances
- 606
What is happening in GZJ right now?
GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief) has two findings, most consequential first. 2 first-time filers in the last 12 months, Algiamed Technologies USA, Inc. and N & C Holdings, LLC (K252712, K252236). The code is crowded, scoring 81 of 100 — 319 companies hold a clearance here and 3 arrived in the last 12 months (GZJ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252712, K252236 |
| Crowding | Context | GZJ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in GZJ?
FDA has cleared 606 devices under product code GZJ since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | |
| K252767 | actiTENS mini | Sublimed | |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | |
| K241228 | TENSWave | Zynex Medical Officer | |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. |
How long does FDA review take for GZJ?
The median FDA review time for GZJ is 112 days, measured across the 606 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GZJ?
openFDA lists 7 recall records against product code GZJ. A recall record covers one firm's corrective action and may span many device lots.
Z-2105-2011TerminatedNeuro Resource Group, Inc.
Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
Z-1440-2012TerminatedSynaptic Corp
Device was distributed without marketing approval.
Z-1207-2007TerminatedAvazzia, Inc.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Z-1208-2007TerminatedAvazzia, Inc.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Z-1209-2007TerminatedAvazzia, Inc.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Showing the 5 most recently initiated of 7. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GZJ?
MAUDE holds 60 adverse-event reports naming product code GZJ, 7 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GZJ unusual?
GZJ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
22 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered GZJ in the last year?
2 companies filed in GZJ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Algiamed Technologies USA, Inc. | K252712 | |
| N & C Holdings, LLC | K252236 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in GZJ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GZJ?
Across the 606 most recent decisions, these applicants filed most often in GZJ.
| Applicant | Recent clearances |
|---|---|
| Biomedical Life Systems, Inc. | 20 |
| Empi | 17 |
| Medical Devices, Inc. | 16 |
| American Imex | 11 |
| Bio-Medical Research, Ltd. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in GZJ files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Biomedical Life Systems, Inc. | 22 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GZJ
Get an email the morning anything changes in GZJ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.