Djo, LLC
Medical device manufacturer in Carlsbad, CA.
12510(k) clearances
1PMA approvals
11recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201653 | Compex Sport Elite 3.0NGX · Traditional | 11/27/2020SE |
| K170918 | Compex Sport EliteNGX · Traditional | 06/20/2017SE |
| K170903 | Compex Wireless USANGX · Traditional | 06/19/2017SE |
| K153704 | StriveGZJ · Abbreviated | 06/03/2016SE |
| K153696 | Chattanooga Revolution WirelessIPF · Traditional | 04/14/2016SE |
| K153224 | VitalStim(R) Plus Electrotherapy SystemIPF · Traditional | 02/17/2016SE |
| K143551 | Compex Wireless USANGX · Traditional | 04/28/2015SE |
| K132284 | Vectra Neo Clinical Therapy SystemIPF · Traditional | 04/10/2014SE |
| K130722 | Aircast Venaflow Elite SystemJOW · Traditional | 06/20/2013SE |
| K124016 | Empi PhoenixIPF · Abbreviated | 05/06/2013SE |
| K122499 | Aircast Venaflow Elite SystemJOW · Traditional | 10/18/2012SE |
| K091700 | Aircast Venaflow Elite SystemJOW · Special | 07/09/2009SE |
PMA approvals
- P910066 Orthologic (TM)1000 Bone Growth Stimulator · 03/04/1994 · 26 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2137-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |
| Z-2136-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |
| Z-2135-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |
| Z-2134-2026 Class II | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494…Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 03/19/2026Open, Classified |
| Z-0722-2026 Class II | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in… | 09/25/2025Open, Classified |
| Z-0010-2022 Class I | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF:…Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial… | 09/07/2021Open, Classified |
| Z-0009-2022 Class I | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5…Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial… | 09/07/2021Open, Classified |
| Z-1985-2019 Class II | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date:…The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear… | 01/17/2019Open, Classified |
| Z-2590-2020 Class II | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic…The device accessories were not labeled with appropriate latex warning. | 06/25/2018Terminated |
| Z-0121-2016 Class II | Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect…Overheating and burning of the wire insulation inside the applicator. | 08/21/2015Terminated |
| Z-1661-2013 Class II | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a…DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and… | 05/28/2013Terminated |