Data / Medical devices / United States / Fasikl Incorporated
Fasikl Incorporated: FDA-registered device maker in Bloomington, MN, United States, 1 510(k) clearance
Fasikl Incorporated is registered with the FDA (registration 3038912617) in Bloomington, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 1, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038912617
- Address
- 8500 Normandale Lake Blvd Ste 400, Bloomington, MN, United States, 55437
- Owner or operator
- Fasikl Incorporated (10093772)
- Roles
- Specification developer
- First device listed
- July 8, 2025
- Registered through
- 2026
- Brand names listed
- Felix NeuroAI Wristband
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| External Upper Limb Tremor Stimulator | QBC | 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 |
|---|---|---|---|---|---|---|
| July 1, 2025 | K250096 | Felix NeuroAI System | QBC | Substantially Equivalent | Fasikl Incorporated | accessdata.fda.gov |
Compare with other makers
Updated July 1, 2025. 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.