Data / Medical devices / France / Winback Europa SAS
Winback Europa SAS: FDA-registered device maker in Biarritz Nouvelle-Aquitaine, France, 3 510(k) clearances
Winback Europa SAS is registered with the FDA (registration 3022747124) in Biarritz Nouvelle-Aquitaine, France. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022747124
- Address
- 20 Avenue Victor Hugo, Biarritz Nouvelle-Aquitaine, France, 64200
- Owner or operator
- Swims SAS (10085110)
- Roles
- Exporter to the US
- First device listed
- May 6, 2022
- Registered through
- 2026
- Brand names listed
- Winback
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 1, 2023 | K220014 | RSHOCK | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| November 1, 2022 | K214090 | Back 3 COLOR | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| September 18, 2017 | K162828 | Winback Back 3SE | PBX | Substantially Equivalent | Winback USA Corp | accessdata.fda.gov |
Compare with other makers
Updated March 1, 2023. 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.