Data / Medical devices / Mexico / DJ Orthopedics De Mexico, S.A. De C.V.
DJ Orthopedics De Mexico, S.A. De C.V.: FDA-registered device maker in TIJUANA Baja California, Mexico, 59 510(k) clearances
DJ Orthopedics De Mexico, S.A. De C.V. is registered with the FDA (registration 9616086) in TIJUANA Baja California, Mexico. It lists 96 device types. The FDA files 59 510(k) clearances under its listings, the newest dated November 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616086
- FEI number
- 3006076154
- Address
- Carretera Libre Tijuana Tecate 20230 Submetropoli El Florido, TIJUANA Baja California, Mexico, 22244
- Owner or operator
- DJO, LLC (9015378)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- April 15, 1998
- Registered through
- 2026
- Brand names listed
- , BAG HOLDERS, 6400, 7400, 8600 Low Back Electrode, A2 WRIST BRACE, A60 ANKLE BRACE, ABDOMINAL, ABDOMINAL SUPPORTS, ABDUCTED THUMB SPICA, AC SPORT BRACE and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2020 | K201653 | Compex Sport Elite 3.0 | NGX | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| July 1, 2020 | K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | NUH | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
| June 28, 2018 | K180865 | ZMI Self-Adhesive Electrodes | GXY | Substantially Equivalent | Zmi Electronics , Ltd. | accessdata.fda.gov |
| August 11, 2016 | K160138 | Adhesive Electrodes | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
| May 5, 2016 | K153520 | Electronic Pulse Stimulator | NUH | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
| September 17, 2014 | K141260 | ELECTRONIC PULSE STIMULATOR | NUH | Substantially Equivalent | Shenzhen Jingkehui Electronic Co.., Ltd. | accessdata.fda.gov |
| April 10, 2014 | K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | IPF | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| July 17, 2013 | K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| May 6, 2013 | K124016 | EMPI PHOENIX | IPF | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| October 18, 2012 | K122499 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| March 5, 2010 | K093324 | EMPI CONTINUUM | IPF | Substantially Equivalent | Empi | accessdata.fda.gov |
| July 9, 2009 | K091700 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| March 18, 2009 | K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | IMJ | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| November 27, 2007 | K071624 | EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR | GZJ | Substantially Equivalent | Everlife Medical Equipment Co., Ltd. | accessdata.fda.gov |
| August 17, 2007 | K071320 | EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 | IPF | Substantially Equivalent | Everlife Medical Equipment Co., Ltd. | accessdata.fda.gov |
| June 29, 2007 | K070890 | EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 | LIH | Substantially Equivalent | Everlife Medical Equipment Co., Ltd. | accessdata.fda.gov |
| June 11, 2007 | K070425 | VITALSTIM EXPERIA | IPF | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| January 26, 2007 | K062354 | VECTRA GENISYS VMS FR | IPF | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| February 24, 2006 | K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | ITH | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| September 21, 2005 | K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | ITH | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| September 8, 2004 | K040662 | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS | ILY | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| April 12, 2004 | K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | IMG | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| December 11, 2003 | K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | IMG | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| December 3, 2003 | K031116 | VECTRA (INTELECT) EPR ULTRASOUND | IMI | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| June 3, 2003 | K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| February 10, 2003 | K023800 | VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| December 6, 2002 | K023347 | VITAL STIM | IPF | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| July 6, 2001 | K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | LSB | Substantially Equivalent | Chattanooga Group, Inc. | accessdata.fda.gov |
| January 13, 2000 | K992454 | VENAFLOW SYSTEM, MODEL 30A | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| November 6, 1998 | K982828 | FORTE, MODELS CPS 400 STIM, CPS 200 STIM | IPF | Substantially Equivalent | Chattanooga Group, Inc. | accessdata.fda.gov |
| November 10, 1997 | K973024 | INTELECT LEGEND ULTRASOUND | IMI | Substantially Equivalent | Chattanooga Group, Inc. | accessdata.fda.gov |
| September 8, 1997 | K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| May 9, 1997 | K970426 | VALUETRODE | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| November 22, 1996 | K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 22, 1996 | K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 22, 1996 | K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963563 | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963561 | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963554 | 24448-010 SECURE-ALL FINGER CONTROL MITT | FMQ | Substantially Equivalent | Tecnol Medical Products, Inc. | accessdata.fda.gov |
| November 12, 1996 | K963492 | PROTECTIVE RESTRAINT | FMQ | Substantially Equivalent | Smith and Nephew Donjoy, Inc. | accessdata.fda.gov |
| November 12, 1996 | K963490 | PROTECTIVE RESTRAINT - BELTS | FMQ | Substantially Equivalent | Smith and Nephew Donjoy, Inc. | accessdata.fda.gov |
| November 12, 1996 | K963489 | WHEEL CHAIR ACCESSORY | FMQ | Substantially Equivalent | Smith and Nephew Donjoy, Inc. | accessdata.fda.gov |
| November 12, 1996 | K963169 | RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL | ITX | Substantially Equivalent | Rapid-Aid Ltd./Ltee | accessdata.fda.gov |
| May 11, 1995 | K946298 | BIOSTIM-HV | IPF | Substantially Equivalent | Progressive Concepts, Inc. | accessdata.fda.gov |
| December 6, 1993 | K925643 | RX FIT MEDICAL STOCKINGS | DWL | Substantially Equivalent | Elastic Therapy, Inc. | accessdata.fda.gov |
| October 25, 1993 | K932900 | AIRCAST VENAFLOW SYSTEM | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| December 30, 1992 | K921608 | PRESSSION, SEQUENTIAL | JOW | Substantially Equivalent | Chattanooga Group, Inc. | accessdata.fda.gov |
| January 14, 1992 | K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | GXY | Substantially Equivalent | Labeltape Meditect, Inc. | accessdata.fda.gov |
| January 18, 1991 | K896817 | MODEL T11 FLUIDOTHERAPY UNIT | LSB | Substantially Equivalent | Henley Intl. | accessdata.fda.gov |
| June 8, 1990 | K902195 | TBD TENS REUSABLE ELECTRODE | GXY | Substantially Equivalent | Empi | accessdata.fda.gov |
| January 28, 1988 | K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| December 11, 1987 | K873368 | TECNOL COMPRESSION KNEE DRESSING | LLK | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. | accessdata.fda.gov |
| September 4, 1987 | K871802 | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | LSB | Substantially Equivalent | Henley Intl. | accessdata.fda.gov |
| June 18, 1985 | K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| June 17, 1980 | K801272 | TECNOL QUICK RELEASE LIMB HOLDER | FMQ | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. | accessdata.fda.gov |
| June 1, 1979 | K790699 | TECNOL BODY HOLDER | FMQ | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair And Table, Medical
- All makers of Stimulator, Muscle, Powered
- All makers of Cable, Electrode
- All makers of Orthosis, Abdominal
- All makers of Shoe, Cast
- All makers of Orthosis, Cervical-Thoracic, Rigid
Updated November 27, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.