Company ยท US
Djo, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (1 in 12 months)
11recalls (5 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOW | Sleeve, Limb, Compressible | 5 |
| ILO | Pack, Hot Or Cold, Water Circulating | 4 |
| IPF | Stimulator, Muscle, Powered | 4 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 |
| IME | Pack, Hot Or Cold, Reusable | 1 |
| IMF | Unit, Chilling | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2026 | K262721 | Spinalogic Bone Growth Stimulator Djo, LLC | LOF |
| Nov 27, 2020 | K201653 | Compex Sport Elite 3.0 Djo, LLC | NGX |
| Jun 20, 2017 | K170918 | Compex Sport Elite Djo, LLC | NGX |
| Jun 19, 2017 | K170903 | Compex Wireless USA Djo, LLC | NGX |
| Jun 3, 2016 | K153704 | Strive Djo, LLC | GZJ |
| Apr 14, 2016 | K153696 | Chattanooga Revolution Wireless Djo, LLC | IPF |
| Feb 17, 2016 | K153224 | VitalStim(R) Plus Electrotherapy System Djo, LLC | IPF |
| Apr 28, 2015 | K143551 | Compex Wireless USA Djo, LLC | NGX |
| Apr 10, 2014 | K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM Djo, LLC | IPF |
| Jun 20, 2013 | K130722 | AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC | JOW |
| May 6, 2013 | K124016 | EMPI PHOENIX Djo, LLC | IPF |
| Oct 18, 2012 | K122499 | AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC | JOW |
| Jul 9, 2009 | K091700 | AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC | JOW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | DJO, LLC Brand Name: DONJOY
Product Name: ICEMAN, W/COLDPAD, NS, RH
Model/Catalog Number: 11-9099
Software Version: No
Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH
The IceMan CLASSIC3 cold therapy Open, Classified |
ILO | None listed |
| May 8, 2026 | DJO, LLC Brand Name: DONJOY
Product Name: ICEMAN W/,UNIV,LOOP,NS,EH
Model/Catalog Number: 11-1424
Software Version: No
Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH
The IceMan CLASSIC3 cold therapy Open, Classified |
ILO | None listed |
| May 8, 2026 | DJO, LLC Brand Name: DONJOY
Product Name: ICEMAN W/,UNIV,LOOP,NS,RH
Model/Catalog Number: 11-1422
Software Version: no
Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH
The IceMan CLASSIC3 cold therapy Open, Classified |
ILO | None listed |
| May 8, 2026 | DJO, LLC 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 r Open, Classified |
ILO | None listed |
| Nov 26, 2025 | DJO, LLC Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 Open, Classified |
IME | None listed |
| Sep 7, 2021 | DJO, LLC Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits: Open, Classified |
ITX | K962840 |
| Sep 7, 2021 | DJO, LLC 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, Open, Classified |
ITX | K955246 |
| Jul 13, 2020 | DJO, LLC 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 Terminated |
IMF | None listed |
| Jan 17, 2019 | DJO, LLC Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC. Open, Classified |
JOW | K964238 |
| Oct 15, 2015 | DJO, LLC 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 electromagneti Terminated |
IMJ | K083433 |
| Jul 3, 2013 | DJO, LLC 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. Terminated |
JOW | K091700 |