Data / Medical devices / United States / Pelvital Usa, Inc.
Pelvital Usa, Inc.: FDA-registered device maker in Eagan, MN, United States, 2 510(k) clearances
Pelvital Usa, Inc. is registered with the FDA (registration 3017230582) in Eagan, MN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 1, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017230582
- Address
- 860 Blue Gentian Rd Suite 200, Eagan, MN, United States, 55121
- Owner or operator
- Pelvital USA, Inc. (10077256)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 18, 2020
- Registered through
- 2027
- Brand names listed
- Flyte, Flyte System MTI-1.5
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Perineometer | HIR | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 1, 2024 | K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | HIR | Substantially Equivalent | Pelvital USA, Inc. | accessdata.fda.gov |
| July 10, 2020 | K200409 | Pelvital System | HIR | Substantially Equivalent | Pelvital USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 1, 2024. 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.