Data / Medical devices / United States / Djo, LLC
Djo, LLC: FDA-registered device maker in Carlsbad, CA, United States, 103 510(k) clearances and 2 PMA approvals
Djo, LLC is registered with the FDA (registration 3017264244) in Carlsbad, CA, United States. It lists 106 device types. The FDA files 103 510(k) clearances and 2 PMA approvals under its listings, the newest dated September 29, 2026. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017264244
- Address
- 5919 Sea Otter Place Suite 200, Carlsbad, CA, United States, 92010
- Owner or operator
- DJO, LLC (9015378)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 15, 1998
- Registered through
- 2026
- Brand names listed
- , BAG HOLDERS, 300PV, 3D ActiveTrac, 6400, 7400, 8600 Low Back Electrode, A2 WRIST BRACE, A60 ANKLE BRACE, ABDOMINAL, ABDOMINAL SUPPORTS 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. Newest 100 of 103.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2026 | K262721 | Spinalogic Bone Growth Stimulator | LOF | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| January 21, 2021 | K202839 | Overlapped Compression Therapy | JOW | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
| 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 |
| February 22, 2018 | K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | GEX | Substantially Equivalent | Litecure, LLC | accessdata.fda.gov |
| June 20, 2017 | K170918 | Compex Sport Elite | NGX | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| June 19, 2017 | K170903 | Compex Wireless USA | NGX | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| August 11, 2016 | K160138 | Adhesive Electrodes | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
| June 3, 2016 | K153704 | Strive | GZJ | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| May 5, 2016 | K153520 | Electronic Pulse Stimulator | NUH | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
| April 14, 2016 | K153696 | Chattanooga Revolution Wireless | IPF | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| April 28, 2015 | K143551 | Compex Wireless USA | NGX | Substantially Equivalent | Djo, LLC | 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 |
| February 12, 2014 | K133274 | VENA PRO | JOW | Substantially Equivalent | Innovamed Health, LLC | accessdata.fda.gov |
| July 17, 2013 | K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| June 20, 2013 | K130722 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | 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 |
| July 15, 2010 | K100441 | XINIWAVE, MODEL XW-18 | NUH | Substantially Equivalent | International Trade Group, Inc. | 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 |
| June 5, 2009 | K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR | GZJ | Substantially Equivalent | Empi | accessdata.fda.gov |
| June 1, 2009 | K090632 | COMPEX REHAB | IPF | Substantially Equivalent | Chattanooga Group | 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 |
| February 9, 2009 | K083140 | COMPEX SPORT PLUS | NGX | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| November 16, 2007 | K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | EGJ | Substantially Equivalent | Empi | accessdata.fda.gov |
| June 11, 2007 | K070425 | VITALSTIM EXPERIA | IPF | Substantially Equivalent | Chattanooga Group | accessdata.fda.gov |
| February 28, 2007 | K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | EGJ | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| February 6, 2007 | K061516 | STAODYN MAX PRESET, MODEL 4470 | GZJ | Substantially Equivalent | Compex Technologies, Inc. | accessdata.fda.gov |
| January 26, 2007 | K062354 | VECTRA GENISYS VMS FR | IPF | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| January 22, 2007 | K061650 | SELECT TENS, MODEL 4600S | GZJ | Substantially Equivalent | Empi | accessdata.fda.gov |
| March 31, 2006 | K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | EGJ | Substantially Equivalent | Iomed, Inc. | 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 |
| April 13, 2005 | K050046 | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S | IPF | Substantially Equivalent | Compex Technologies, Inc. | 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 22, 2003 | K033192 | RH-950 | KTB | Substantially Equivalent | Iomed, Inc. | 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 |
| July 10, 2003 | K031115 | RH-900 | KTB | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| June 3, 2003 | K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| April 8, 2003 | K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | EGJ | Substantially Equivalent | Empi | 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 |
| June 18, 2002 | K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | IPF | Substantially Equivalent | Empi | accessdata.fda.gov |
| April 17, 2002 | K011880 | COMPEX SPORT | NGX | Substantially Equivalent | Compex S.A. | accessdata.fda.gov |
| July 6, 2001 | K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | LSB | Substantially Equivalent | Chattanooga Group, Inc. | accessdata.fda.gov |
| October 18, 2000 | K001522 | TRANSQ3 | KTB | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| August 31, 2000 | K001712 | 3D ACTIVETRAC | ITH | Substantially Equivalent | The Saunders Group | accessdata.fda.gov |
| August 1, 2000 | K001410 | PHORESOR MODEL PM2000 | KTB | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| January 13, 2000 | K992454 | VENAFLOW SYSTEM, MODEL 30A | JOW | Substantially Equivalent | Aircast, Inc. | accessdata.fda.gov |
| March 2, 1999 | K982668 | PHORESOR II,MODEL PM900 | EGJ | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| December 28, 1998 | K983484 | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE | EGJ | Substantially Equivalent | Empi | 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 6, 1998 | K982410 | SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE | GZJ | Substantially Equivalent | Rehabilicare, Inc. | accessdata.fda.gov |
| November 3, 1998 | K983206 | SMALL VAGINAL/RECTAL ELECTRODE | KPI | Substantially Equivalent | Empi | accessdata.fda.gov |
| March 27, 1998 | K974855 | PHORESOR II, MODEL PM900 | KTB | Substantially Equivalent for Some Indications | Iomed, 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 |
| August 14, 1997 | K972054 | INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE | KPI | Substantially Equivalent | Empi | accessdata.fda.gov |
| August 14, 1997 | K971542 | ORTHO DX NEUROMUSCULAR STIMULATOR | IPF | Substantially Equivalent | Rehabilicare, Inc. | accessdata.fda.gov |
| May 9, 1997 | K970426 | VALUETRODE | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
| April 22, 1997 | K970307 | MINNOVA PELVIC FLOOR STIMULATION SYSTEM | KPI | Substantially Equivalent | Empi | 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 |
| January 19, 1996 | K954126 | TRANSQ ELECTRODE PHORESOR II | KTB | Substantially Equivalent for Some Indications | Iomed, Inc. | accessdata.fda.gov |
| November 28, 1994 | K943898 | SAUNDERS ELECTRONIC INCLINOMETER | KQX | Substantially Equivalent | The Saunders Group | accessdata.fda.gov |
| August 23, 1994 | K941389 | EMPI TAPE PATCHES | KGX | Substantially Equivalent | Empi | accessdata.fda.gov |
| July 26, 1994 | K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | EGJ | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| July 26, 1994 | K932621 | RH-801/GS MODEL TRANSQ(R)1 | EGJ | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| July 26, 1994 | K932620 | RH-806/GS MODEL TRANSQ(R)2 | EGJ | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| July 15, 1994 | K915444 | DUPEL IONTOPHORESIS DEVICE | EGJ | Substantially Equivalent | Empi | accessdata.fda.gov |
| July 14, 1994 | K925806 | RH-801, MODEL TRANSQ | EGJ | Substantially Equivalent | Iomed, Inc. | accessdata.fda.gov |
| July 14, 1994 | K925800 | RH-806, MODEL TRANSQ | EGJ | Substantially Equivalent | Iomed, 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 |
| December 20, 1991 | K914621 | IONTOPHORESIS DEVICE, MODIFICATION | EGJ | Unknown | Iomed, Inc. | accessdata.fda.gov |
| December 20, 1991 | K914264 | TRANSQ 2 | EGJ | Unknown | Iomed, Inc. | accessdata.fda.gov |
| November 15, 1991 | K912015 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 | EGJ | Substantially Equivalent | Empi | 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 |
| May 10, 1990 | K896444 | IONTOPHORESIS DEVICE - ELECTRODE RH 800 | EGJ | Unknown | Iomed, Inc. | 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 |
| June 18, 1985 | K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | GXY | Substantially Equivalent | Axelgaard Mfg. Co., Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 17, 2025 | P210016 | ManaFuse | LOF | 0 | January 17, 2025 | accessdata.fda.gov |
| March 4, 1994 | P910066 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | LOF | 26 | January 23, 2020 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 19, 2026 | 98638 | Class II | Ongoing | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3 cold therapy unit helps reduce pain and swell | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | accessdata.fda.gov |
| September 25, 2025 | 97610 | Class II | Ongoing | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn. | accessdata.fda.gov |
| September 7, 2021 | 88623 | Class I | Ongoing | 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 | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-l | accessdata.fda.gov |
| April 12, 2021 | 87727 | Class II | Terminated | DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck. | failed rivet at the chafe tab of arm sling. | accessdata.fda.gov |
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Updated September 29, 2026. 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.