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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Chilling | IMF | Class 1 | Physical Medicine | No | 2009-08-27 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2023-04-26 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2007-12-27 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2011-08-17 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2006-04-27 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 1998-06-19 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2009-08-27 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2015-05-01 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2015-05-01 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2015-05-01 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2007-12-19 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1998-06-19 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2011-12-15 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 1999-08-04 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2002-01-03 |
| System, Pressure Measurement, Intermittent | JFC | Class 1 | Physical Medicine | No | 2004-11-01 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 1998-06-19 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2001-11-26 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2006-02-10 |
| Equipment, Traction, Powered | ITH | Class 2 | Physical Medicine | No | 2009-08-27 |
| Head Halter, Traction | IRS | Class 1 | Physical Medicine | No | 2002-09-12 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2009-08-27 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2009-08-27 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2009-08-27 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2009-08-27 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-06-28 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2002-02-01 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2007-03-15 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2013-06-27 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2007-10-19 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 1999-08-04 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2007-03-15 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2011-12-15 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2004-03-16 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2009-08-27 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2004-03-16 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2007-02-26 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 1998-06-19 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 1998-06-19 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2011-12-15 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-05-05 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2021-05-05 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-05-05 |
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | Class 2 | Physical Medicine | No | 2009-08-27 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1998-06-19 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 1998-06-19 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2009-06-11 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 2009-08-27 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1998-08-05 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2011-12-15 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2009-08-27 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2014-12-02 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 1998-06-19 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 1999-08-04 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2015-06-26 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2002-12-11 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2007-03-15 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2010-09-09 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2002-02-01 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 1998-06-19 |
| Vibrator, Therapeutic | IRO | Class 1 | Physical Medicine | No | 2009-08-27 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 1998-06-19 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2011-12-15 |
| Unit, Fluidotherapy | LSB | Class 2 | Physical Medicine | No | 2018-05-07 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2009-08-27 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2007-12-27 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1998-06-19 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1998-06-19 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2009-08-27 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2004-03-16 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 1998-06-19 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 1999-08-04 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2004-11-01 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2009-08-27 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2014-02-20 |
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 1998-06-19 |
| Legging, Compression, Non-Inflatable | LLK | Class 2 | General Hospital | No | 2007-12-19 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2008-02-12 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2007-11-26 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1998-06-19 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2007-08-29 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2011-10-21 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 1998-06-19 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 1998-06-19 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 1998-06-19 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2004-03-16 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2009-08-27 |
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2011-12-15 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2009-11-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1998-06-19 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 1998-06-19 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2009-08-27 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2005-11-22 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2004-03-16 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 1998-08-05 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1998-06-19 |
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