Data / Medical devices / United States / Djo, LLC
Djo, LLC: FDA-registered device maker in Vista, CA, United States, 6 510(k) clearances and 3 PMA approvals
Djo, LLC is registered with the FDA (registration 3012446970) in Vista, CA, United States. It lists 11 device types. The FDA files 6 510(k) clearances and 3 PMA approvals under its listings, the newest dated September 29, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012446970
- FEI number
- 2020737
- Address
- 3151 Scott St, Vista, CA, United States, 92081
- Owner or operator
- DJO, LLC (9015378)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 19, 1998
- Registered through
- 2026
- Brand names listed
- A2 WRIST BRACE, ABDUCTED THUMB SPICA, ACROMIOCLAVICULAR BRACE-UNIV, ACTYTOE FOOT BRACE, ACTYTOE LIFT, ACTYTOE NIGHT SPLINT, ADVANTAGE STABILIZING ELASTIC WRIST, ANAFORM ARM SLEEVE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cage, Knee | ITM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Generator, Shock-Wave, For Pain Relief | NBN | 3 | Repackager or relabeler | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| September 29, 2026 | K262721 | Spinalogic Bone Growth Stimulator | LOF | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| April 14, 2017 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | NUH | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
| October 18, 2012 | K122499 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| July 9, 2009 | K091700 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | 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 |
| January 13, 2000 | K992454 | VENAFLOW SYSTEM, MODEL 30A | JOW | Substantially Equivalent | Aircast, Inc. | 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 |
| January 8, 2016 | P080028 | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY | NBN | 1 | February 5, 2020 | 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 |
|---|---|---|---|---|---|---|
| January 17, 2019 | 82967 | Class II | Ongoing | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC. | The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements. | accessdata.fda.gov |
| June 25, 2018 | 85445 | Class II | Terminated | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed o | The device accessories were not labeled with appropriate latex warning. | accessdata.fda.gov |
| August 21, 2015 | 72168 | Class II | Terminated | Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio | Overheating and burning of the wire insulation inside the applicator. | accessdata.fda.gov |
| May 28, 2013 | 65493 | Class II | Terminated | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis. | DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire). | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Bone Growth, Non-Invasive
- All makers of Generator, Shock-Wave, For Pain Relief
- All makers of Cage, Knee
- All makers of Sleeve, Limb, Compressible
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Joint, Knee, External Brace
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.