Data / Medical devices / Switzerland / Pontemed AG
Pontemed AG: FDA-registered device maker in Arborn Thurgau, Switzerland, 1 510(k) clearance
Pontemed AG is registered with the FDA (registration 3048050691) in Arborn Thurgau, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3048050691
- Address
- Stickereistrasse 4, Arborn Thurgau, Switzerland, 9320
- Owner or operator
- PonteMed AG (10096130)
- Roles
- Specification developer
- First device listed
- July 6, 2026
- Registered through
- 2026
- Brand names listed
- PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 17, 2026 | K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | KPI | Substantially Equivalent | Pontemedag | accessdata.fda.gov |
Compare with other makers
Updated April 17, 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.