DJO FRANCE SAS

FDA Device Registration & Listing · MOUGUERRE Pyrenees-Atlantiques, FR · Registration 3007502541

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007502541
FEI Number
3007502541
Entity Name
DJO FRANCE SAS
City/State/Country
MOUGUERRE Pyrenees-Atlantiques, FR
Establishment Address
Centre Europeen de Fret, 3 rue de Bethar,, MOUGUERRE Pyrenees-Atlantiques 64990, FR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
DJO, LLC (Owner Number: 9015378)
Owner / Operator Contact Address
5919 Sea Otter Place, Suite 200, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Intelect Transport 2 Ultrasound Intelect Transport 2 Combo (Neurostimulator and Ultrasound) Cybertech Chairback Frame Standard Chairback LSO Low Profile DONJOY Low Profile EXOS FORM II Cybertech Premium Plus DONJOY Lite SACRO-LUMBAR SUPPORTS Electrode SIL/CARBON 6x8CM BLK SPORT WRAP KIT IMAK SMART GLOVE W/THUMB SHOULDER CRADLE LACE-UP WRIST SUPPORT QUICK RELOAD ECONOMY SHOULDER IMMOBILIZER VELOCITY LS PADDED FINGER COT PNEUMATIC ARMBAND VCOMFORT FORM WRIST THUMB A2 WRIST BRACE LERMAN SHOULDER ORTHOSIS ELBOW RANGER PERFORMER ELBOW SUPPORT ABDUCTED THUMB SPICA LITES ELBOW VISCO SCOI SHOULDER BRACE COMFORT FORM WRIST IMAK ELBOW WRAP ELASTIC WRIST BRACE CLINIC TENNIS ELBOW ELASTIC ELBOW SUPPORT DONJOY ELBOW GUARD VDELUXE WRIST FOREARM DONJOY SPORTS THIGH WRAP ARM IMMOBILIZER SLING SAMMONS PRESTON, ARMBAND WRIST-O-PRENE SUPPORT SURROUND FLOAM ELBOW ELASTIC SHOULDER IMMOBILIZER BOOMERANG WRIST SUPPORT ANAFORM WRIST WRAP TENNIS ELBOW BRACE TRIZONE ELBOW BRACE BIONIC ELBOW BRACE TRIZONE CALF SLEEVE ANAFORM ARM SLEEVE ANAFORM CALF SLEEVE ANAFORM SHIN SPLINT SLEEVE MANUFORCE WRIST BRACE EPIFORCE BIONIC REEL-ADJUST WRIST BRACE X-ACT ROM ELBOW BRACE ADVANTAGE STABILIZING ELASTIC WRIST PERFORMANCE WRIST WRAP LONG THUMB SPICA II ARTHRITIS GLOVES ACTYTOE NIGHT SPLINT ACTYTOE LIFT ACTYTOE FOOT BRACE SOFTOES CONDILAX ELBOW SUPPORT ERGOFORM THUMB BRACE CARPAFORM WRIST BRACE RHIZOFORM THUMB BRACE DIGIFORM WRIST-FINGER BRACE DUOFORM WRIST BRACE ADULT DUOFORM WRIST BRACE PEDIATRIC ULTRASLING PRO DIGIFORM FINGER SPLINT ULTRASLING IV ACROMIOCLAVICULAR BRACE-UNIV MAYO CLINIC ELBOW BRACE SHOULDER IMMOBILIZER ENHANCED HYBRID ELS BRACE PLANTAR FASCIITIS STRETCH SAFETY WRIST BRACE WESTERN WRIST SLEEVE ELBOW IMMOBILIZER POSTERIOR ELBOW BRACE POSTURE CLAVICLE SUPPORT SULLY SHOULDER CONTOURED ELASTI-WRAP I-ROM ELBOW CALF SLEEVE UNIVERSAL WRIST SUPPORT BURNHAM THUMB QUICK-FIT WRIST BRACE VQ ABDUCTED THUMB SPICA COLLES SPLINT ELBOW SLEEVE DEFIANCE PINCH GUARD CTS WRIST SUPPORT KODEL CLAVICLE NEO TENNIS ELBOW SPECIALTY SHOULDER IMMOBILIZER DELUXE ROM ELBOW KODEL SHOULDER IMMOB PALM MET ELBOW SPIDER PAD Intelect RPW 2 Intelect RPW VQ, UNIVERSAL ANKLE BRACE AIR STIRRUP II ANKLE BRACE JUMP BRACE SPORT-STIRRUP ECONOSOC SURROUND FLOAM ANKLE ON TRACK TAPE PATCHES DOUBLE STRAP ANKLE WRAP STIRRUP ANKLE SPRT LITES VISCO ANKLE AIRGO KALLASSY ANKLE SUPPORT AIRHEEL KALLASSY LACE-UP ANKLE ALP II A60 ANKLE BRACE MALOLAX ELASTIC ANKLE ANKLET Exos FreeMotion Ankle Advanced Dynamic ROM Orthosis Trizone Ankle Brace Donjoy ACHILLOFORCE AIR Bionic Ankle Brace MALLEOFORCE AIR-STIRRUP™ ANKLE BRACE AirSport+ EXOS® FREE MOTION ANKLE STABILIZING SPEED PRO ANKLE WRAP AIRLIFT PTTD ANKLE BRACE STRAPILAX ELASTIC ANKLE ANKLE BRACES PODALIB NOIR PEDIATRIC AIR-STIRRUP ROCKETSOC EXCELERATOR ANKLE STIRRUP SURROUND GEL ANKLE DONJOY SPORTS ANKLE ACTIVE ANKLE T1 ORTHOSIS FORTILAX ELASTIC ANKLE DELUX ANKLE AIRSPORT BRACE DRYTEX,ROCKETSOC SUPER-LITE A.F.O STABILIZING ANKLE UNIVERSAL ANKLE BRACE VELOCITY LITE ANKLE BRACE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2009-08-27
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2009-08-27
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2009-08-27
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2009-08-27
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 1998-08-05
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2025-08-27
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 1998-06-19
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2009-08-27
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2009-08-27
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2009-08-27
HCC Device, Biofeedback Neurology Class 2 882.5050 2009-08-27
LIH Interferential Current Therapy Neurology Class 2 882.5890 2009-08-27
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5860 2009-08-27
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2020-11-19
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 1998-06-19

Official Correspondent

Dave Hunter

US Agent Details

Dave Hunter Email: dave.hunter@djoglobal.com Phone: (858) 2458747

Related Public Records

Same Entity

DJO, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008261413 DJO CANADA INC. Mississauga Ontario, CA
3003678958 DJO GLOBAL SWITZERLAND SARL Ecublens Vaud, CH
3012446970 DJO, LLC Vista, CA, US
3007740591 DJO Global / Germany Freiburg Baden-Wurttemberg, DE
3014694377 DJO, LLC Fort Worth, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007502541. Last updated year: 2026. Please use registration number 3007502541 when referencing this establishment in official correspondence.
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