Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010675856

FEI Number

3010675856

Entity Name

KINETEC USA

City/State/Country

Jackson, WI, US

Establishment Address

N174W21475 Alcan Drive, Jackson, WI 53037, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

KIT 4 CERVICAL COLLAR - ADULT CERVICAL COLLAR - CHILDREN Corset 4-6 years Suspension hammock small Corset 0-2 years Suspension hammock large Exchange pad for pelvic sling Corset 2-3 years KIT 2 Equi Complet pelvic sling Kinetec Kooler Relief Pad Reusable Dr. Aktive CCT Manosplint Ohio Manosplint Ohio F Manosplint Wisconsin Manosplint Ohio S Manosplint Carolina Kinetec Centura B&W Kinetec Centura Kinetec Spectra XL Kinetec Centura Lite Kinetec 6080 Kinetec Performa Kinetec Kinetec Maestra Kinetec Breva Kinetec USA Kinetec Prima Advance Kinetec Prima XL Kinetec Spectra Kinetec Spectra Essential Kinetec Centura Elbow Module Kinetec Kompanion Dr. Aktive CCT KIT 3 Dr. Aktive OrthoSole 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
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2022-07-19
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2016-01-08
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2016-01-08
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-01-18
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-01-18
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2013-12-03
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2020-01-14
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2016-01-08
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2018-06-20
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2013-12-03

Official Correspondent

Lori Kalsow

US Agent Details

No US Agent registered (Local establishment).

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
8020836	Kinetec SAS	Tournes Ardennes, FR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010675856. Last updated year: 2026. Please use registration number 3010675856 when referencing this establishment in official correspondence.