Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616086

FEI Number

3006076154

Entity Name

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

City/State/Country

TIJUANA Baja California, MX

Establishment Address

CARRETERA LIBRE TIJUANA TECATE, 20230 SUBMETROPOLI EL FLORIDO, TIJUANA Baja California 22244, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered 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 + 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 BUCKS TRACTION KNEE SLING Wraparound Limb Holder KNEE AND OTHER STINGS TRACTION ACCESSORIES Dura-Stick + 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMF	Unit, Chilling	Physical Medicine	Class 1	890.5940	2009-08-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-04-26
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-08-27
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2007-12-27
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2011-08-17
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2006-04-27
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	1998-06-19
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2009-08-27
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2015-05-01
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2015-05-01
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-05-01
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1998-06-19
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2011-12-15
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	1999-08-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-27
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2002-01-03
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2004-11-01
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	1998-06-19
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2001-11-26
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2006-02-10
ITH	Equipment, Traction, Powered	Physical Medicine	Class 2	890.5900	2009-08-27
IRS	Head Halter, Traction	Physical Medicine	Class 1	890.5925	2002-09-12
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2014-12-03
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-27
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
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
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2014-12-03
KTZ	Caliper	Orthopedic	Class 1	888.4150	2009-08-27
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2013-06-28
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2002-02-01
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-03-15
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	2009-08-27
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-03-26
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2007-10-19
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	1999-08-04
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-03-26
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	Class 1	890.3420	2007-03-15
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2010-12-28
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2010-02-03
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2011-12-15
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2004-03-16
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2015-06-19
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2009-08-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2004-03-16
IPR	Crutch	Physical Medicine	Class 1	890.3150	2007-02-26
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	1998-06-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-27
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	1998-06-19
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2011-12-15
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
IMJ	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2009-08-27
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	1998-06-19
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	1998-06-19
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2009-06-11
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2009-08-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-27
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	1998-08-05
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2011-12-15
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2009-08-27
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-12-02
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1998-06-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	1999-08-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-01-27
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2009-08-27
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-27
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2015-06-26
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2002-12-11
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-05-05
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2007-03-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-09-09
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2002-02-01
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
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	1998-06-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2009-08-27
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
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-01-28
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-06-19
LGF	Component, Cast	Orthopedic	Class 1	888.5940	1998-06-19
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2011-12-15
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
LSB	Unit, Fluidotherapy	Physical Medicine	Class 2	890.5100	2018-05-07
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2009-08-27
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2007-12-27
LSB	Unit, Fluidotherapy	Physical Medicine	Class 2	890.5100	2016-01-29
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1998-06-19
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1998-06-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-03-15
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2009-08-27
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2009-08-27
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2004-03-16
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	1998-06-19
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	1999-08-04
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2004-11-01
HWA	Impactor	Orthopedic	Class 1	888.4540	2009-08-27
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-27
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2014-02-20
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2007-12-19
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	1998-06-19
LLK	Legging, Compression, Non-Inflatable	General Hospital	Class 2	880.5780	2007-12-19
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2008-02-12

Official Correspondent

Dave Hunter

US Agent Details

Dave Hunter Email: dave.hunter@djoglobal.com Phone: (858) 2458747

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-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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3009134624	CSafe Global	Dayton, OH, US
3015527848	WEG Surgical Solutions	Greensboro, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616086. Last updated year: 2026. Please use registration number 9616086 when referencing this establishment in official correspondence.