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
Electrode, Cutaneous GXY
Unit, Fluidotherapy LSB
Sling, Arm, Overhead Supported ILE
Goniometer, Ac-Powered KQX
Stimulator, Muscle, Powered IPF
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat IMG
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Stimulator, Neuromuscular, External Functional GZI
Device, Biofeedback HCC
Component, Cast LGF
Helmet, Cranial, For Protective Use NDA
Belt, Pelvic, Traction HSQ
Device, Iontophoresis, Other Uses EGJ
Orthosis, Corrective Shoe KNP
Caliper KTZ
Chair And Table, Medical KMN
Sleeve, Limb, Compressible JOW
Orthosis, Limb Brace IQI
Stimulator, Muscle, Powered, For Muscle Conditioning NGX
Orthosis, Cervical IQK
Stimulator, Bone Growth, Non-Invasive LOF
Board, Arm (With Cover), Sterile BTX
Bag, Ice KYR
Stimulator, Electrical, Transcutaneous, For Arthritis NYN
Restraint, Protective FMQ
Stimulator, Electrical, Non-Implantable, For Incontinence KPI
Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
Cover, Cast KIA
Joint, Ankle, External Brace ITW
Table, Mechanical INW
Interferential Current Therapy LIH
Orthosis, Lumbo-Sacral IPY
Cushion, Wheelchair IMP
Components, Exercise IOD
Dressing, Wound, Occlusive NAD
Binder, Abdominal FSD
Cable, Electrode IKD
Pack, Hot Or Cold, Reusable IME
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis PDZ
Powered Laser Surgical Instrument GEX
Lamp, Infrared, Therapeutic Heating ILY
Unit, Heating, Powered IRQ
Device, Iontophoresis, Specific Uses KTB
Pad, Heating, Powered IRT
Equipment, Traction, Powered ITH
Pack, Heat, Moist IMA
Protector, Skin Pressure FMP
Apparatus, Traction, Non-Powered HST
Joint, Knee, External Brace ITQ
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
Orthosis, Cervical-Thoracic, Rigid IQF
Tape And Bandage, Adhesive KGX
Tourniquet, Nonpneumatic GAX
Impactor HWA
Adaptor, Dressing ILD
Joint, Hip, External Brace ITS
Unit, Chilling IMF
Aid, Transfer IKX
Splint, Clavicle IQJ
Orthosis, Lumbar IQE
Orthosis, Abdominal KTD
Orthosis, Rib Fracture, Soft IPX
Joint, Knee, External Limb Component ISY
Support, Arm IOY
Splint, Abduction, Congenital Hip Dislocation IOZ
Dynamometer, Nonpowered HRW
Stocking, Medical Support (For General Medical Purposes) FQL
Bandage, Cast ITG
Pack, Hot Or Cold, Water Circulating ILO
Exerciser, Powered BXB
Splint, Hand, And Components ILH
Crutch IPR
Plinth INT
Shoe, Cast IPG
Massager, Therapeutic, Electric ISA
Device, External Penile Rigidity LKY
Bars, Parallel, Exercise IOE
Bandage, Elastic FQM
Surgical Table Cushion LWG
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Legging, Compression, Non-Inflatable LLK
Stirrup, External Brace Component ITC
Support, Scrotal, Therapeutic FQJ
System, Isokinetic Testing And Evaluation IKK
Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
Head Halter, Traction IRS
Table, Powered INQ
Cover, Limb IPM
Vibrator, Therapeutic IRO
Tips And Pads, Cane, Crutch And Walker INP
Walker, Mechanical ITJ
System, Pressure Measurement, Intermittent JFC
Accessories, Traction ILZ
Insoles, Medical KYS
Orthopedic Manual Surgical Instrument LXH
Lift, Patient, Non-Ac-Powered FSA
Accessories, Catheter KGZ
Lift, Patient, Ac-Powered FNG
Sling, Arm ILI
Cage, Knee ITM
Orthosis, Sacroiliac, Soft IPW
Pack, Hot Or Cold, Disposable IMD
Accessories, Wheelchair KNO
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat IMJ
Component, Traction, Non-Invasive KQZ

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