Data / Medical devices / United States / SEKO MedTec Solutions
SEKO MedTec Solutions: FDA-registered device maker in Oakdale, PA, United States, 2 510(k) clearances
SEKO MedTec Solutions is registered with the FDA (registration 3010032952) in Oakdale, PA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 28, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010032952
- Address
- 300 Crown Court Suite 320, Oakdale, PA, United States, 15071
- Owner or operator
- SEKO MedTec Solutions (10042726)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- January 22, 2021
- Registered through
- 2026
- Brand names listed
- ActaStim, PregSense
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Home Uterine Activity Monitor | LQK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| May 28, 2021 | K210025 | INVU by Nuvo | LQK | Substantially Equivalent | Nuvo- Group , Ltd. | accessdata.fda.gov |
| March 27, 2020 | K191401 | PregSense | LQK | Substantially Equivalent | Nuvo- Group , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 28, 2021. 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.