Data / Medical devices / France / X6 Innovations
X6 Innovations: FDA-registered device maker in Paris Ile-de-France, France, 3 510(k) clearances
X6 Innovations is registered with the FDA (registration 3014166044) in Paris Ile-de-France, France. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014166044
- Address
- 128 rue La Boetie, Paris Ile-de-France, France, 75008
- Owner or operator
- X6 Innovations (10056375)
- Roles
- Exporter to the US, Specification developer
- First device listed
- February 14, 2023
- Registered through
- 2026
- Brand names listed
- Perifit, Perifit Care+, Perifit Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Perineometer | HIR | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 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 |
|---|---|---|---|---|---|---|
| January 26, 2024 | K231785 | Perifit Pump | HGX | Substantially Equivalent | X6 Innovations | accessdata.fda.gov |
| December 20, 2023 | K231780 | Perifit Care+ | HIR | Substantially Equivalent | X6 Innovations | accessdata.fda.gov |
| February 10, 2023 | K221476 | Perifit | HIR | Substantially Equivalent | X6 Innovations | accessdata.fda.gov |
Compare with other makers
Updated January 26, 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.