Data / Medical devices / France / Djo France SAS
Djo France SAS: FDA-registered device maker in MOUGUERRE Pyrenees-Atlantiques, France, 5 510(k) clearances
Djo France SAS is registered with the FDA (registration 3007502541) in MOUGUERRE Pyrenees-Atlantiques, France. It lists 13 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 28, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007502541
- Address
- Centre Europeen de Fret 3 rue de Bethar, MOUGUERRE Pyrenees-Atlantiques, France, 64990
- Owner or operator
- DJO, LLC (9015378)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 19, 1998
- Registered through
- 2026
- Brand names listed
- A2 WRIST BRACE, A60 ANKLE BRACE, ABDUCTED THUMB SPICA, ACROMIOCLAVICULAR BRACE-UNIV, ACTIVE ANKLE T1 ORTHOSIS, ACTYTOE FOOT BRACE, ACTYTOE LIFT, ACTYTOE NIGHT SPLINT and more
Devices it lists
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 28, 2018 | K180865 | ZMI Self-Adhesive Electrodes | GXY | Substantially Equivalent | Zmi Electronics , Ltd. | accessdata.fda.gov |
| February 17, 2016 | K153224 | VitalStim(R) Plus Electrotherapy System | IPF | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| February 9, 2009 | K083140 | COMPEX SPORT PLUS | NGX | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| April 12, 2004 | K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | IMG | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| December 11, 2003 | K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | IMG | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Lumbar
- All makers of Massager, Therapeutic, Electric
- All makers of Joint, Knee, External Brace
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated June 28, 2018. 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.