FDA Registration
Active
🇺🇸 United States
DJO, LLC
Reg #: 3017264244
·
FEI: 3017264244
·
Expires 2026
Products
106
Proprietary Names
329
Establishment Types
5
Classifications
106
Registration Details
- Registration Name
- DJO, LLC
- Registration Number
- 3017264244
- FEI Number
- 3017264244
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5919 Sea Otter Place, Suite 200
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K874469
- PMA Number
- P210016
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 |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2017-01-27 |
| Unit, Fluidotherapy | LSB | Class 2 | Physical Medicine | No | 2009-08-27 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 1998-06-19 |
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2016-06-17 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2009-08-27 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2009-08-27 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2009-08-27 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2009-08-27 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2009-08-27 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 1998-06-19 |
| Helmet, Cranial, For Protective Use | NDA | Class 1 | Physical Medicine | No | 2006-08-28 |
| Belt, Pelvic, Traction | HSQ | Class 1 | Orthopedic | No | 1998-06-19 |
| Device, Iontophoresis, Other Uses | EGJ | Class 2 | Physical Medicine | No | 2014-12-03 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2002-02-01 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2009-08-27 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2009-08-27 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2008-03-26 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1998-06-19 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2009-08-10 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1998-06-19 |
| Stimulator, Bone Growth, Non-Invasive | LOF | Class 2 | Orthopedic | No | 2025-07-07 |
| Board, Arm (With Cover), Sterile | BTX | Class 1 | General, Plastic Surgery | No | 2021-08-12 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2004-03-16 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2014-12-03 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2007-12-27 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2014-12-03 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-05-05 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2011-10-21 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2011-12-15 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 1998-06-19 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2009-08-27 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2009-08-27 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 1998-06-19 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2009-08-27 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 1999-08-04 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2010-06-02 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1998-06-19 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2009-06-11 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2002-01-03 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2023-02-08 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-02-08 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-02-08 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2009-08-27 |
| Device, Iontophoresis, Specific Uses | KTB | Class 2 | Physical Medicine | No | 2014-12-03 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2021-05-05 |
| Equipment, Traction, Powered | ITH | Class 2 | Physical Medicine | No | 2009-08-27 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2008-02-12 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 1998-06-19 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 1998-06-19 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1998-06-19 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2015-06-26 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2004-03-16 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2014-12-03 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2002-12-11 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2009-08-27 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2011-12-15 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 1998-06-19 |
| Unit, Chilling | IMF | Class 1 | Physical Medicine | No | 2009-08-27 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2011-08-17 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2002-02-01 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1998-08-05 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 1998-06-19 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 1998-06-19 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 1999-08-04 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 1998-06-19 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 1998-08-05 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 2009-08-27 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2011-10-21 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2014-12-02 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2004-11-01 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2009-08-27 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1998-06-19 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2007-02-26 |
| Plinth | INT | Class 1 | Physical Medicine | No | 2009-08-27 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2004-03-16 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2020-11-19 |
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2011-12-15 |
| Bars, Parallel, Exercise | IOE | Class 1 | Physical Medicine | No | 2009-11-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2004-03-16 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2007-12-27 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 1999-08-04 |
| Legging, Compression, Non-Inflatable | LLK | Class 2 | General Hospital | No | 2007-12-19 |
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 1998-06-19 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2011-12-15 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2001-09-27 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2006-04-27 |
| Head Halter, Traction | IRS | Class 1 | Physical Medicine | No | 2002-09-12 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2009-08-27 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 1998-06-19 |
| Vibrator, Therapeutic | IRO | Class 1 | Physical Medicine | No | 2009-08-27 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2007-12-27 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2011-12-15 |
| System, Pressure Measurement, Intermittent | JFC | Class 1 | Physical Medicine | No | 2004-11-01 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 1999-08-04 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2005-11-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2001-09-18 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2009-08-27 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1998-06-19 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2009-08-27 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1998-06-19 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 1998-06-19 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2009-11-13 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2009-08-27 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 1998-06-19 |
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | Class 2 | Physical Medicine | No | 2009-08-27 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2001-11-26 |
Proprietary Names
Dura-Stick +
Dura-Stick Premium
ARM ELEVATOR SLING
ARM ELEVATOR STING
Saunders Electronic Inclinometer
CAST COMPONENT
OrthoDx Neuromuscular Stimulator
Saunders Pelvic Traction Belt
Hybresis
I-Bresis
MaxTrax Air 2
MaxTrax Standard 2
CORRECTIVE SHOE
WALKERS
VARIOUS TYPES
RH-801/GS Model TransQ®1
IONTOPHORESIS
Dupel
Vascular System
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
NXT GEN Cervical Collar
CERVICAL COLLARS
CERVICAL#PHYSICAL MEDICINE
ManaFuse
Quantum Adaptable
Select
Protective Restraint - Belts
VenaPro
Minnova
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
TTFT
CPM PADS
Staodyn MaxPreset Model 4470
BINDER
ABDOMINAL
TL7
TL7 Chattanooga Leadwires
Active Back Brace
Compex RX
Chattanooga Continuum
Body Holder
Secure All One Piece Body Holder
HOT OR COLD PACK
Steam Pack to Chattanooga Heating Unit
Chattanooga Heating Unit
TransQ1 Iontophoresis Electrode RH 800
Strive
Compex Strive
Secure All Pelvic Holder
Ultra Care Vest with Safety Sleeve
300PV
RH-900 Electrode
VENAFLOW ELITE
VenaFlow Elite System & Accessories
Champion (Hybresis) Iontophoretic Drug Delivery Device
Electrode SIL/CARBON 6x8CM BLK
Multiple Sizes of Steam Packs
PROTECTOR
ELBOW PROTECTORS
HEEL
SKIN PRESSURE#GENERAL HOSPITAL
ZYNEX CERVICAL TRACTION DEVICE
ZYNEX LUMBAR TRACTION DEVICE
BUCKS TRACTION
KNEE SLING
WEEKENDER
PLAYMAKER XPERT SLEEVE
Velocity Extension Cuff
OA Go
CryoKnee Brace
ROAM OA KNEE BRACE
SUPPORT EVEREST ICE II SLEEVE
Ultra Care Vest Body Holder
3D ActiveTrac
Phoresor Model PM2000
RH-801, Ag/AgCl, Model TransQ
NM III
Intelect Transport 2 Ultrasound
Intelect Transport 2 Combo (Neurostimulator and Ultrasound)
Tape Patches
Limb Holder Quick Release
Stimulator, muscle, powered
Chattanooga Continuum KIT
Active
Phoresor II, Model PM900
Dura Stick
Quick Release Limb Holder
Iontophoresis Device, Modification (TQ1 Modified RH-801)
RH-950 Electrode
TransQ2, Electrode RH-805
HIP BRACE II
Excyabir Hip Brace
HIP BRACE
Nylatex, wrap to hold cold pad, Accessories
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
Phoresor II Auto, Mode PM800 Modification
VenaGo
VenaFlow Sterile Cuff
Dura-Stick BG
CLAVICLE SUPPORTS
TransQ3 Electrode
Cybertech Chairback Frame
Standard Chairback
LSO Low Profile
DONJOY Low Profile
EXOS FORM II
Cybertech Premium Plus
DONJOY Lite
SACRO-LUMBAR SUPPORTS
Personal Limb Holder
ABDOMINAL SUPPORTS
RIB BELT
AK SUSPENSION WRAP
Protective Restraint
Theratherm
VenaFlow System
Innova® Reusable Comfortpulse Electrodes
HIP ABDUCTION KIT
New Life
RX Fit
Compex Wireless USA
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
VENAFLOW AND ARTERIA
Small Vaginal/Rectal Electrode
OptiFlex®-K1 Standard
ARTROMOT®-E2
OptiFlex®-S
ARTROMOT®-E2 Compact
OptiFlex®-K1 Classic
OptiFlex®-K1 Comfort Chip
ARTROMOT®-SP3 Standard Chip
ARTROMOT®-SP3 Comfort Chip
ARTROMOT® ACTIVE-K
ARTROMOT®-SP3 Standard
ARTROMOT®-SP3 Comfort
ARTROMOT®-S4
WRIST MANAGEMENT
Maxima
Action Patch
Compex Sport
Compex Fitness Trainer
Compex Sport 4
Compex SP4
Intelect RPW 2
Intelect RPW
Chattanooga Deluxe Exerciser
Chattanooga Standard Exerciser
Chattanooga Std Exerciser Retail Pk
ATHLETIC TAPE
TransQ Electrode, Phoresor II
Surgical Table Cushion
Empi Elite
CATHETER STRAP
Compression Knee Dressing
DONJOY VISTA REHABI
HEAD HALTER
Adapta
Galaxy 5
REGION 3D TABLE 120V
Montane Andes 7
Galaxy 3
LIMB#PHYSICAL MEDICINE
REPLACEMENT WRAPS
Cane, Crutch, & Walker Tips & Pads
LOAD SENSOR KIT
KNEE AND OTHER STINGS
TRACTION ACCESSORIES
Performance Snap
AC SPORT BRACE
6400, 7400, 8600 Low Back Electrode
DEFIANCE
CUSTOM ADJUSTABLE OA DEFIANCE
DEFIANCE III, CCMI
FUNCTIONAL KNEE BRACE
DEFIANCE III FEMALE FOURCE
DEFIANCE III
SI BELT
DONJOY SI BELT
Saunders Sacroiliac Belt
System 2 Zippered Body Holder
Dura-Stick + Snap
Dura-Stick
, BAG HOLDERS
WHEELCHAIR PADS
WHEELCHAIR#PHYSICAL MEDICINE
Wraparound Limb Holder
Compex Sport Elite
MW-1000 Iontophoretic Electrode
Iomed
Secure All Finger Control Mitt
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device