FDA product code QHH: Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
QHH is the FDA product code for non-implanted nerve stimulator for pain associated with irritable bowel syndrome (ibs). It is a Class II device, regulated under 21 CFR 876.5340 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under QHH, 4 in the last five years, from 3 different applicants. The average 510(k) review took 127 days (median 108); 125 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.
Classification
| Field | Value |
|---|---|
| Device name | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) |
| Device class | Class II |
| Regulation | 21 CFR 876.5340 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QHH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 90 |
| 2023 | 1 | 199 |
| 2024 | 1 | 153 |
| 2025 | 2 | 97 |
Compare with all 510(k) review times · Search every QHH clearance
Top QHH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neuraxis | 3 | 2025-10-16 |
| Transtimulation Research, Inc. | 1 | 2023-09-14 |
| Dyansys, Inc. | 1 | 2020-12-29 |
Most recent QHH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252024 | Neuraxis | NeurAxis IB-Stim (01-1020) | 2025-10-16 | 108 |
| K250451 | Neuraxis | NeurAxis IB-Stim (01-1020) | 2025-05-15 | 86 |
| K241533 | Neuraxis | NeurAxis IB-Stim (01-1020) | 2024-10-30 | 153 |
| K230526 | Transtimulation Research, Inc. | TEA Device | 2023-09-14 | 199 |
| K202940 | Dyansys, Inc. | First Relief v1 | 2020-12-29 | 90 |
Recalls for QHH devices
openFDA lists no recalls for product code QHH.
Frequently asked questions
What is FDA product code QHH?
QHH is the FDA product code for non-implanted nerve stimulator for pain associated with irritable bowel syndrome (ibs). It is a Class II device, regulated under 21 CFR 876.5340 and reviewed by the Gastroenterology and Urology panel.
What device class is QHH?
Class II, regulation 21 CFR 876.5340. Typical premarket route: 510(k).
How long does a 510(k) take for product code QHH?
Across 5 cleared submissions the average was 127 days from receipt to decision (median 108).
Which companies have the most QHH clearances?
Neuraxis (3); Transtimulation Research, Inc. (1); Dyansys, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QHH
- Run a recall and safety report across every QHH manufacturer
- Watch product code QHH 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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