FDA Registration Active 🇹🇳 Tunisia

DJO Tunisia

Reg #: 3011120089 · FEI: 3011120089 · Expires 2026
Products
12
Proprietary Names
158
Establishment Types
2
Classifications
12

Registration Details

Registration Name
DJO Tunisia
Registration Number
3011120089
FEI Number
3011120089
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rue Jabir Ibn Aflah, Route Sidi Mansour Km 2
City
Sfax
Country
TN

Regulatory Submissions

510(k) Number
K170918

Owner / Operator

Firm Name
DJO, LLC
Operator Number
9015378
Address
5919 Sea Otter Place, Suite 200
City
Carlsbad
State
CA
Postal Code
92010
Country
US
Correspondent
Dave Hunter

US Agent

Business Name
DJO, LLC
Contact Name
Dave Hunter
Address
5919 Sea Otter Place, Suite 200
City
Carlsbad
State
CA
ZIP
92010
Country
US
Phone
858 2458747

Products

Device Name Product Code
Orthosis, Lumbar IQE
Stimulator, Muscle, Powered, For Muscle Conditioning NGX
Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
Stimulator, Electrical, Transcutaneous, For Arthritis NYN
Cover, Limb IPM
Sling, Arm ILI
Orthosis, Lumbo-Sacral IPY
Joint, Knee, External Brace ITQ
Binder, Abdominal FSD
Orthosis, Limb Brace IQI
Stocking, Medical Support (For General Medical Purposes) FQL
Joint, Ankle, External Brace ITW

Proprietary Names

Cybertech Chairback Frame Standard Chairback LSO Low Profile DONJOY Low Profile EXOS FORM II Cybertech Premium Plus DONJOY Lite SACRO-LUMBAR SUPPORTS Compex Sport Elite LIMB#PHYSICAL MEDICINE REPLACEMENT WRAPS AC SPORT BRACE WEEKENDER PLAYMAKER XPERT SLEEVE Velocity Extension Cuff OA Go CryoKnee Brace ROAM OA KNEE BRACE SUPPORT EVEREST ICE II SLEEVE BINDER ABDOMINAL 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 New Life RX Fit 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

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device