DJO, LLC
Vista, CA, US
DJO, LLC appears in FDA device records in Vista, CA. FDA records list 12 510(k) clearances between and , 27 PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for DJO, LLC between 2009 and 2020. The busiest year on record is 2016, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201653 | Compex Sport Elite 3.0 | NGX | Substantially Equivalent | |
| K170918 | Compex Sport Elite | NGX | Substantially Equivalent | |
| K170903 | Compex Wireless USA | NGX | Substantially Equivalent | |
| K153704 | Strive | GZJ | Substantially Equivalent | |
| K153696 | Chattanooga Revolution Wireless | IPF | Substantially Equivalent | |
| K153224 | VitalStim(R) Plus Electrotherapy System | IPF | Substantially Equivalent | |
| K143551 | Compex Wireless USA | NGX | Substantially Equivalent | |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | IPF | Substantially Equivalent | |
| K130722 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | |
| K124016 | EMPI PHOENIX | IPF | Substantially Equivalent | |
| K122499 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | |
| K091700 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012446970 | 2020737 | DJO, LLC | 3151 Scott St, Vista, CA 92081 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITMCage, Knee
- NBNGenerator, Shock-Wave, For Pain Relief
- ITQJoint, Knee, External Brace
- ILYLamp, Infrared, Therapeutic Heating
- IQIOrthosis, Limb Brace
- IRTPad, Heating, Powered
- JOWSleeve, Limb, Compressible
- LOFStimulator, Bone Growth, Non-Invasive
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1985-2019 | 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. | Class II | Open, Classified | |
| Z-2590-2020 | 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 of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient. | The device accessories were not labeled with appropriate latex warning. | Class II | Terminated | |
| Z-0121-2016 | 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 frequency of 27.12 megahertz to generate deep heat within body tissues. | Overheating and burning of the wire insulation inside the applicator. | Class II | Terminated | |
| Z-1661-2013 | 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). | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain