Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022747124

FEI Number

3022747124

Entity Name

WINBACK EUROPA SAS

City/State/Country

Biarritz Nouvelle-Aquitaine, FR

Establishment Address

20 Avenue Victor Hugo, Biarritz Nouvelle-Aquitaine 64200, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Swims SAS (Owner Number: 10085110)

Owner / Operator Contact Address

Les Bureaux du Parc, Villeneuve Loubet, FR-06 06270, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K214090

PMA Number

N/A

All Registered Proprietary Names

Winback Winback Winback

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-05-06
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2023-03-31
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-09

Official Correspondent

Clemence Roux

US Agent Details

Ramona Von Leden Business: SWIMS America Email: ramona@winback.com Phone: (914) 4095773

Related Public Records

Same Entity

Swims SAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022747124. Last updated year: 2026. Please use registration number 3022747124 when referencing this establishment in official correspondence.