FDA Registration
Active
🇹🇳 Tunisia
DJO Tunisie
Reg #: 3007615436
·
FEI: 3007615436
·
Expires 2026
Products
12
Proprietary Names
158
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- DJO Tunisie
- Registration Number
- 3007615436
- FEI Number
- 3007615436
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zone Industrielle Poudriere 1, Rue 13 Aout,
- City
- SFAX
- Country
- TN
Regulatory Submissions
- 510(k) Number
- K083140
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1998-08-05 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 1998-06-19 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 1998-06-19 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 1998-06-19 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1998-06-19 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2009-08-10 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2011-10-21 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1998-06-19 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1998-06-19 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1998-06-19 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2017-11-14 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2017-11-14 |
Proprietary Names
Cybertech Chairback Frame
Standard Chairback
LSO Low Profile
DONJOY Low Profile
EXOS FORM II
Cybertech Premium Plus
DONJOY Lite
SACRO-LUMBAR SUPPORTS
LIMB#PHYSICAL MEDICINE
REPLACEMENT WRAPS
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
BINDER
ABDOMINAL
New Life
RX Fit
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
WEEKENDER
PLAYMAKER XPERT SLEEVE
Velocity Extension Cuff
OA Go
CryoKnee Brace
ROAM OA KNEE BRACE
SUPPORT EVEREST ICE II SLEEVE
AC SPORT BRACE
Compex Sport Elite
Establishment Types
Manufacture Medical Device