Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017264244

FEI Number

3017264244

Entity Name

DJO, LLC

City/State/Country

Carlsbad, CA, US

Establishment Address

5919 Sea Otter Place, Suite 200, Carlsbad, CA 92010, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

DJO, LLC (Owner Number: 9015378)

Owner / Operator Contact Address

5919 Sea Otter Place, Suite 200, Carlsbad, CA 92010, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983206

PMA Number

N/A

All Registered 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 Dupel 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 Chattanooga Continuum 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-27
LSB	Unit, Fluidotherapy	Physical Medicine	Class 2	890.5100	2009-08-27
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	1998-06-19
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2016-06-17
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-27
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2009-08-27
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2009-08-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2009-08-27
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2009-08-27
LGF	Component, Cast	Orthopedic	Class 1	888.5940	1998-06-19
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-12-03
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2006-08-28
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	1998-06-19
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2014-12-03
LSB	Unit, Fluidotherapy	Physical Medicine	Class 2	890.5100	2018-05-07
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2002-02-01
KTZ	Caliper	Orthopedic	Class 1	888.4150	2009-08-27
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2009-08-27
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2014-12-03
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-03-26
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-01-28
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2014-12-03
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1998-06-19
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2009-08-10
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	1998-06-19
LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic	Class 2	890.5870	2025-07-07
BTX	Board, Arm (With Cover), Sterile	General, Plastic Surgery	Class 1	878.3910	2021-08-12
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2004-03-16
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-12-03
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2014-12-03
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-04-23
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2014-12-03
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2021-05-05
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-05-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-05-05
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2016-05-03
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2016-05-03
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2011-10-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-05-05
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2011-12-15
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	1998-06-19
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2009-08-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2009-08-27
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2009-08-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-27
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2009-08-27
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2009-08-27
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2009-08-27
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	1998-06-19
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2009-08-27
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	1999-08-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2010-06-02
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2016-06-17
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2016-06-17
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	1998-06-19
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2009-06-11
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-03-15
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2002-01-03
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2014-12-03
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2023-02-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-02-08
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-02-08
IRQ	Unit, Heating, Powered	Physical Medicine	Class 1	890.5950	2009-08-27
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2016-06-17
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2016-06-17
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2016-06-17
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-12-03
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-12-03
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2014-12-03
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2014-12-03
KTB	Device, Iontophoresis, Specific Uses	Physical Medicine	Class 2	890.5525	2014-12-03
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2014-12-03
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2021-05-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-05-05
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-05-05
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-05-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2009-08-27
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2009-08-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2010-02-03
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-08-27
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2008-02-12
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1998-06-19
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1998-06-19
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1998-06-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2015-06-26
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2016-06-17
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2010-12-28
KTB	Device, Iontophoresis, Specific Uses	Physical Medicine	Class 2	890.5525	2016-06-17
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2016-06-17
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2004-03-16
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-27
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2009-08-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2009-08-27
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2009-08-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-12-03
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-12-03
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-12-03
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2002-12-11
HWA	Impactor	Orthopedic	Class 1	888.4540	2009-08-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-04-26
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-06-26
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2014-04-15
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-04-15
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2014-04-15
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2014-04-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-04-15
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2014-04-15
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2014-04-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-27
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2009-08-27
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2011-12-15
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2009-08-27
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2014-12-03
KTB	Device, Iontophoresis, Specific Uses	Physical Medicine	Class 2	890.5525	2014-12-03
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	1998-06-19
IMF	Unit, Chilling	Physical Medicine	Class 1	890.5940	2009-08-27
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2014-12-03
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-12-03
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-12-03
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2011-08-17
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2015-03-17
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2016-06-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2004-03-16
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-12-16
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-12-16
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2020-12-16
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-06-30
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-03-26
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-27
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2015-04-29
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2002-02-01
KTB	Device, Iontophoresis, Specific Uses	Physical Medicine	Class 2	890.5525	2016-06-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	1998-08-05
LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic	Class 2	890.5870	2005-10-07
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	1998-06-19
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	1998-04-15
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	1998-06-19
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	1999-08-04
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-27
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2009-11-11
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-06-27
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2013-06-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2013-06-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-03-26
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	1998-06-19
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2014-12-03
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	1998-08-05
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2009-08-27
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2011-10-21
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2009-08-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-27
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-12-02
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-11-07
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-11-07
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2017-11-07
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2004-11-01
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-03-15
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2014-12-03

Official Correspondent

Dave Hunter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DJO, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008261413	DJO CANADA INC.	Mississauga Ontario, CA
3003678958	DJO GLOBAL SWITZERLAND SARL	Ecublens Vaud, CH
3012446970	DJO, LLC	Vista, CA, US
3007740591	DJO Global / Germany	Freiburg Baden-Wurttemberg, DE
3014694377	DJO, LLC	Fort Worth, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017264244. Last updated year: 2026. Please use registration number 3017264244 when referencing this establishment in official correspondence.