Data / Medical devices / United States / K-Fit Kegel Toner, LLC
K-Fit Kegel Toner, LLC: FDA-registered device maker in Albany, OR, United States, 1 510(k) clearance
K-Fit Kegel Toner, LLC is registered with the FDA (registration 3014405438) in Albany, OR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 18, 2018. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3014405438
- Address
- 2373 Cluster Oak Ave NW, Albany, OR, United States, 97321
- Owner or operator
- K-fit Kegel Toner, LLC (10057321)
- Roles
- Complaint file establishment
- First device listed
- March 24, 2026
- Registered through
- 2027
- Brand names listed
- K-fit Kegel Toner, KM518
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| January 18, 2018 | K163288 | Pelvifine Pelvic Muscle Trainer | KPI | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 18, 2018. 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.