Data / Medical devices / Tunisia / DJO Tunisia

DJO Tunisia: FDA-registered device maker in Sfax, Tunisia, 2 510(k) clearances

Name: DJO Tunisia FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DJO Tunisia is registered with the FDA (registration 3011120089) in Sfax, Tunisia. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011120089
Address: Rue Jabir Ibn Aflah Route Sidi Mansour Km 2, Sfax, Tunisia, 3000
Owner or operator: DJO, LLC (9015378)
Roles: Manufacturer, Repackager or relabeler
First device listed: June 19, 1998
Registered through: 2026
Brand names listed: A2 WRIST BRACE, A60 ANKLE BRACE, ABDOMINAL, ABDUCTED THUMB SPICA, AC SPORT BRACE, ACROMIOCLAVICULAR BRACE-UNIV, ACTIVE ANKLE T1 ORTHOSIS, ACTYTOE FOOT BRACE and more

Devices it lists

Device	Product code	Class	Role	Source
Binder, Abdominal	FSD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cover, Limb	IPM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthosis, Lumbo-Sacral	IPY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sling, Arm	ILI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Manufacturer	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
June 20, 2017	K170918	Compex Sport Elite	NGX	Substantially Equivalent	Djo, LLC	accessdata.fda.gov
February 9, 2009	K083140	COMPEX SPORT PLUS	NGX	Substantially Equivalent	Chattanooga Group	accessdata.fda.gov

Compare with other makers

Updated June 20, 2017. 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.