Data / Medical devices / United States / Uroval Inc/Folkerts
Uroval Inc/Folkerts: FDA-registered device maker in Manhattan, KS, United States, 1 510(k) clearance
Uroval Inc/Folkerts is registered with the FDA (registration 3008361680) in Manhattan, KS, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 11, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008361680
- Address
- 1220 Marlatt Ave, Manhattan, KS, United States, 66502
- Owner or operator
- UroVal Inc/Folkerts (10032175)
- Roles
- Manufacturer
- First device listed
- April 15, 2010
- Registered through
- 2026
- Brand names listed
- UROVAL INC.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 11, 2009 | K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | IKN | Substantially Equivalent | Uroval | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2009. 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.