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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

DeviceProduct codeClassRoleSource
Stimulator, Electrical, Non-Implantable, For IncontinenceKPI2Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 17, 2026K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPISubstantially EquivalentPontemedagaccessdata.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.