DJO, LLC

FDA Regulatory Profile

Summary

Total Recalls
7 (2 Class I)
510(k) Clearances
12
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0722-2026Class IICold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02September 25, 2025
Z-0010-2022Class IUltra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, locatSeptember 7, 2021
Z-0009-2022Class IGEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributeSeptember 7, 2021
Z-1985-2019Class IIAircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31,January 17, 2019
Z-2590-2020Class IIThis is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATJune 25, 2018
Z-0121-2016Class IIMonode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave DiAugust 21, 2015
Z-1661-2013Class IIVenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump May 28, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K201653Compex Sport Elite 3.0November 27, 2020
K170918Compex Sport EliteJune 20, 2017
K170903Compex Wireless USAJune 19, 2017
K153704StriveJune 3, 2016
K153696Chattanooga Revolution WirelessApril 14, 2016
K153224VitalStim(R) Plus Electrotherapy SystemFebruary 17, 2016
K143551Compex Wireless USAApril 28, 2015
K132284VECTRA NEO CLINICAL THERAPY SYSTEMApril 10, 2014
K130722AIRCAST VENAFLOW ELITE SYSTEMJune 20, 2013
K124016EMPI PHOENIXMay 6, 2013
K122499AIRCAST VENAFLOW ELITE SYSTEMOctober 18, 2012
K091700AIRCAST VENAFLOW ELITE SYSTEMJuly 9, 2009