Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020160

FEI Number

6347

Entity Name

RUNLITE S.A.

City/State/Country

SOUMAGNE Liege, BE

Establishment Address

9 AVENUE DE LA COOPERATION, MICHEROUX, SOUMAGNE Liege 4630, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RUNLITE SA (Owner Number: 8020160)

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

3D-Lite 3D-Lite X-Lite 3D-Lite X-Lite 3D-Lite 3D-Lite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	1989-07-20
LGF	Component, Cast	Orthopedic	Class 1	888.5940	1989-07-20
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	1987-04-03
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1989-07-20
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	1989-07-20

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

RUNLITE SA

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 8020160. Last updated year: 2026. Please use registration number 8020160 when referencing this establishment in official correspondence.