Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020836

FEI Number

3006734242

Entity Name

Kinetec SAS

City/State/Country

Tournes Ardennes, FR

Establishment Address

Zone Industrielle de Tournes, Rue Maurice Périn, Tournes Ardennes F-08090, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kinetec USA, Inc. (Owner Number: 10045573)

Owner / Operator Contact Address

N174W21475 Alcan Drive, Jackson, WI 53037, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kinetec Breva Kinetec Maestra Kinetec 6080 Kinetec Centura Elbow Module Kinetec Spectra Kinetec Spectra Essential Kinetec Kinetec USA Kinetec Centura Kinetec Prima Advance Kinetec Centura B&W Kinetec Performa Kinetec Centura Lite Kinetec Spectra XL Kinetec Prima XL Kinetec Kompanion Kinetec Kinevia Kinevia AL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2013-12-03

Official Correspondent

Lori Kalsow

US Agent Details

Lori Kalsow Business: Kinetec USA, Inc. Email: lori.kalsow@kinetecusa.com Phone: (262) 6771248

Related Public Records

Same Entity

Kinetec USA, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010675856	KINETEC USA	Jackson, WI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020836. Last updated year: 2026. Please use registration number 8020836 when referencing this establishment in official correspondence.