Data / Medical devices / Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence (QON): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Implanted Electrical Device Intended For Treatment Of Fecal Incontinence (product code QON, Class 3, 21 CFR 876.5270). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QON
- Device class
- 3
- Regulation
- 876.5270
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 1 |
| China | 1 |
| Malaysia | 1 |
Makers of Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
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 |
|---|---|---|---|---|---|---|---|---|
| Axonics, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Wabasha, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Enfield, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.