Data / Medical devices / Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) (QHH): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) (product code QHH, Class 2, 21 CFR 876.5340). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on October 16, 2025, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QHH
- Device class
- 2
- Regulation
- 876.5340
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| India | 1 |
| Switzerland | 1 |
Makers of Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Neuraxis, Inc | Carmel, IN, United States | Complaint file establishment, Specification developer | 2 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Neurostimulation Medtech Private Limited | Chennai Tamil Nadu, India | Manufacturer | 1 | December 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Transtimulation Research Inc | Pasadena, CA, United States | Manufacturer | 1 | September 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gmi Corporation | Franklin, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theia Holding SA | La Chaux-de-Fonds Neuchatel, Switzerland | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.