FDA Registration Active 🇲🇽 Mexico

DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.

Reg #: 9616086 · FEI: 3006076154 · Expires 2026
Products
96
Proprietary Names
263
Establishment Types
5
Classifications
96

Registration Details

Registration Name
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Registration Number
9616086
FEI Number
3006076154
Status
Active
Expiry Year
2026
Initial Importer
No
Address
CARRETERA LIBRE TIJUANA TECATE, 20230 SUBMETROPOLI EL FLORIDO
City
TIJUANA Baja California
Country
MX

Regulatory Submissions

510(k) Number
K160138

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
Unit, Chilling IMF
Electrode, Cutaneous GXY
Surgical Table Cushion LWG
Aid, Transfer IKX
Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
Sling, Arm, Overhead Supported ILE
Lift, Patient, Ac-Powered FNG
Interferential Current Therapy LIH
Stimulator, Muscle, Powered IPF
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Restraint, Protective FMQ
Orthosis, Limb Brace IQI
Adaptor, Dressing ILD
Components, Exercise IOD
Pack, Hot Or Cold, Reusable IME
System, Pressure Measurement, Intermittent JFC
Orthosis, Abdominal KTD
Component, Traction, Non-Invasive KQZ
Dressing, Compression MHW
Equipment, Traction, Powered ITH
Head Halter, Traction IRS
Stimulator, Neuromuscular, External Functional GZI
Device, Biofeedback HCC
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat IMG
Caliper KTZ
Accessories, Arthroscopic NBH
Orthosis, Corrective Shoe KNP
Sleeve, Limb, Compressible JOW
Stimulator, Electrical, Transcutaneous, For Arthritis NYN
Support, Hernia EXN
Joint, Knee, External Limb Component ISY
Prosthesis, Thigh Socket, External Component ISS
Support, Scrotal, Therapeutic FQJ
Shoe, Cast IPG
Lamp, Infrared, Therapeutic Heating ILY
Tape And Bandage, Adhesive KGX
Crutch IPR
Accessories, Wheelchair KNO
Joint, Hip, External Brace ITS
Cover, Cast KIA
Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
Pad, Heating, Powered IRT
Stimulator, Muscle, Powered, For Muscle Conditioning NGX
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat IMJ
Binder, Abdominal FSD
Cover, Limb IPM
Cable, Electrode IKD
Dynamometer, Nonpowered HRW
Orthosis, Lumbar IQE
Walker, Mechanical ITJ
Chair And Table, Medical KMN
Bandage, Cast ITG
Apparatus, Traction, Non-Powered HST
Accessories, Traction ILZ
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
Tourniquet, Nonpneumatic GAX
Goniometer, Nonpowered KQW
Transducer, Ultrasonic, Diagnostic ITX
Splint, Clavicle IQJ
Orthosis, Rib Fracture, Soft IPX
Vibrator, Therapeutic IRO
Component, Cast LGF
Orthosis, Thoracic IPT
Unit, Fluidotherapy LSB
Lift, Patient, Non-Ac-Powered FSA
Tips And Pads, Cane, Crutch And Walker INP
Joint, Knee, External Brace ITQ
Accessories, Catheter KGZ
Cushion, Wheelchair IMP
Orthosis, Cervical-Thoracic, Rigid IQF
Orthosis, Lumbo-Sacral IPY
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Pack, Hot Or Cold, Water Circulating ILO
Impactor HWA
Operating Room Accessories Table Tray FWZ
Stirrup, External Brace Component ITC
Legging, Compression, Non-Inflatable LLK
Pack, Heat, Moist IMA
Basin, Emesis FNY
Sling, Arm ILI
Binder, Breast HEF
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
Joint, Ankle, External Brace ITW
Protector, Skin Pressure FMP
Support, Arm IOY
Bandage, Elastic FQM
Pack, Hot Or Cold, Disposable IMD
Device, External Penile Rigidity LKY
Orthosis, Sacroiliac, Soft IPW
Orthosis, Cervical IQK
Cage, Knee ITM
Unit, Heating, Powered IRQ
Insoles, Medical KYS
Bag, Ice KYR
Splint, Abduction, Congenital Hip Dislocation IOZ
Splint, Hand, And Components ILH

Proprietary Names

Nylatex, wrap to hold cold pad, Accessories Dura Stick Electrode SIL/CARBON 6x8CM BLK Surgical Table Cushion ARM ELEVATOR SLING ARM ELEVATOR STING Body Holder 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 CPM PADS Performance Snap HOT OR COLD PACK LOAD SENSOR KIT ABDOMINAL SUPPORTS BUCKS TRACTION COMPRESSION KNEE DRESSING HEAD HALTER Dura-Stick + Dura-Stick BG Personal Limb Holder 6400, 7400, 8600 Low Back Electrode MaxTrax Air 2 MaxTrax Standard 2 CORRECTIVE SHOE WALKERS VARIOUS TYPES VENAFLOW AND ARTERIA Quick Release Limb Holder Vascular System Hernia Belt AK SUSPENSION WRAP VenaFlow Sterile Cuff AIR-LIMB AIR-LIMB AND ACCESSORIES VENAFLOW ELITE VenaFlow Elite System & Accessories , BAG HOLDERS WHEELCHAIR PADS WHEELCHAIR#PHYSICAL MEDICINE Protective Restraint - Belts HIP BRACE II Excyabir Hip Brace HIP BRACE BINDER ABDOMINAL LIMB#PHYSICAL MEDICINE REPLACEMENT WRAPS TL7 TL7 Chattanooga Leadwires Active Back Brace Compex RX Chattanooga Continuum Dura-Stick + Snap Dura-Stick Cybertech Chairback Frame Standard Chairback LSO Low Profile DONJOY Low Profile EXOS FORM II Cybertech Premium Plus DONJOY Lite SACRO-LUMBAR SUPPORTS ZYNEX CERVICAL TRACTION DEVICE ZYNEX LUMBAR TRACTION DEVICE KNEE SLING Wraparound Limb Holder KNEE AND OTHER STINGS TRACTION ACCESSORIES Dura-Stick Premium ROLIMETR ROLIMETER AND ACCESSORIES CLAVICLE SUPPORTS RIB BELT Limb Holder Quick Release CAST COMPONENT M.P35A PLUS AquaFlex 3-Point Hyperextension Brace Cane, Crutch, & Walker Tips & Pads Ultra Care Vest with Safety Sleeve WEEKENDER PLAYMAKER XPERT SLEEVE Velocity Extension Cuff OA Go CryoKnee Brace ROAM OA KNEE BRACE SUPPORT EVEREST ICE II SLEEVE System 2 Zippered Body Holder CATHETER STRAP EXCYABIR W/ COLD UNIT EXCYABIR SHORT W/ COLD UNIT CRYOKNEE W/ COLD UNIT CRYOKNEE W/ COLD PAD COLD THERAPY DEVICE MODEL 1100 COLD THERAPY DEVICE DR. KOOL HYPOTHERMIC SYSTEM Secure All One Piece Body Holder Protective Restraint Secure All Pelvic Holder Compression Knee Dressing Multiple Sizes of Steam Packs O.R. Table Pad AC SPORT BRACE THERAPEUTIC MEDICAL BINDER 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 PROTECTOR ELBOW PROTECTORS HEEL SKIN PRESSURE#GENERAL HOSPITAL ATHLETIC TAPE Secure All Finger Control Mitt Stimulator, muscle, powered Chattanooga Continuum KIT SI BELT DONJOY SI BELT Saunders Sacroiliac Belt VenaFlow System NXT GEN Cervical Collar CERVICAL COLLARS CERVICAL#PHYSICAL MEDICINE DEFIANCE CUSTOM ADJUSTABLE OA DEFIANCE DEFIANCE III, CCMI FUNCTIONAL KNEE BRACE DEFIANCE III FEMALE FOURCE DEFIANCE III Steam Pack to Chattanooga Heating Unit Chattanooga Heating Unit HIP ABDUCTION KIT WRIST MANAGEMENT Intelect Transport 2 Ultrasound Intelect Transport 2 Combo (Neurostimulator and Ultrasound) Ultra Care Vest Body Holder

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Remanufacture Medical Device Export Device to the United States But Perform No Other Operation on Device