Data / Medical devices / United States / Relevium Labs, Incorporated
Relevium Labs, Incorporated: FDA-registered device maker in Oxford, OH, United States, 2 510(k) clearances
Relevium Labs, Incorporated is registered with the FDA (registration 3012697062) in Oxford, OH, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 4, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012697062
- Address
- 4663 Katie Ln, Oxford, OH, United States, 45056
- Owner or operator
- Relevium Labs, Incorporated (10052161)
- Roles
- Specification developer
- First device listed
- June 22, 2016
- Registered through
- 2026
- Brand names listed
- Yarlap, Yarlap II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Specification developer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| May 4, 2016 | K160773 | Yarlap II | KPI | Substantially Equivalent | International Trade Group, Inc. | accessdata.fda.gov |
| April 24, 2015 | K141643 | YARLAP | KPI | Substantially Equivalent | International Trade Group, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Biofeedback
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
Updated May 4, 2016. 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.