FDA product code · Neurology
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
Product code NUH covers Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II device regulated under 21 CFR 882.5890. FDA has cleared 229 devices in this code, 11 of them in the last 12 months. Median review time across the 229 most recent decisions is 148 days. openFDA lists no recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.5890
- Review panel
- Neurology
- Clearances
- 229
What is happening in NUH right now?
NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter) has two findings, most consequential first. 4 first-time filers in the last 12 months, including Globalcare Medical Technology Co., Ltd. and DYNAPULSE MEDICAL LLC (K253896, K251958, K252688, K243131). The code is crowded, scoring 88 of 100 — 117 companies hold a clearance here and 11 arrived in the last 12 months (NUH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253896, K251958, K252688, K243131 |
| Crowding | Context | NUH: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.
What does product code NUH cover?
NUH is FDA's product code for Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II device regulated under 21 CFR 882.5890.
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Source: openFDA device/classification · record NUH · retrieved
How many devices has FDA cleared in NUH?
FDA has cleared 229 devices under product code NUH since the 510(k) programme began in 1976, 11 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | |
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. | |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | |
| K251958 | VEINOPLUS Back | Dynapulse Medical | |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd | |
| K243131 | Triathlon Pro | Sigma Biomedical | |
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. |
How long does FDA review take for NUH?
The median FDA review time for NUH is 148 days, measured across the 229 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 NUH?
openFDA lists no recall records against product code NUH. That is the absence of a record, not a guarantee of safety.
Source: openFDA device/recall · retrieved
How many adverse events are reported for NUH?
MAUDE holds 19 adverse-event reports naming product code NUH, 5 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 NUH unusual?
NUH 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 | |
| 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 | |
| 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 | |
| 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
14 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 NUH in the last year?
4 companies filed in NUH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Globalcare Medical Technology Co., Ltd. | K253896 | |
| DYNAPULSE MEDICAL LLC | K251958 | |
| Bozhou Rongjian Medical Appliance Co., Ltd. | K252688 | |
| Sigma Biomedical | K243131 |
"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 NUH?
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 NUH?
Across the 229 most recent decisions, these applicants filed most often in NUH.
| Applicant | Recent clearances |
|---|---|
| Everyway Medical Instruments Co.,Ltd | 14 |
| Hivox Biotek, Inc. | 11 |
| Well-Life Healthcare Limited | 11 |
| Shenzhen Kentro Medical Electronics Co., Ltd. | 9 |
| Omron Healthcare, Inc. | 7 |
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 NUH 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 |
|---|---|---|
| Shenzhen Osto Technology Company Limited | 10 | 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 NUH
Get an email the morning anything changes in NUH — 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.