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DJO, LLC

Last updated September 17, 2026

Information

Country: US
Address: 5919 Sea Otter Place, Carlsbad, CA, 92010
Website: djoglobal.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 760-734-3161
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3017264244
DUNS Number: 081840873

Catalogue (2587)

Page 52 of 52

Device	Model / Reference	Registries	Class	Status
Bell-Horn	11250S	FDA UDI	Class II	Active
Bell-Horn	20010L	FDA UDI	Class II	Active
Donjoy Performance	DP163CT07	FDA UDI	Class I	Active
Donjoy Performance	DP157ES01-BLK-Y	FDA UDI	Class I	Active
Procare	79-90881	FDA UDI	Class I	Active
Bell-Horn	11570L	FDA UDI	Class II	Unknown
Donjoy	11-1631-0824	FDA UDI	Class II	Active
Bell-Horn	118002X	FDA UDI	Class II	Active
Bell-Horn	11560XL	FDA UDI	Class II	Active
Dr Comfort	132332	FDA UDI	Class I	Active
Bell-Horn	112482X	FDA UDI	Class II	Active
Donjoy	11-9099	FDA UDI	Class II	Active
Bell-Horn	11310S-LONG	FDA UDI	Class II	Unknown
Procare	155-79-97757	FDA UDI	Class I	Active
Donjoy Performance	DP181EB01-BLK-M	FDA UDI	Class I	Active
Bell-Horn	11000S-LONG	FDA UDI	Class II	Active
Non Franchise	88-040000064234	FDA UDI	Class I	Active
Dr Comfort	701412	FDA UDI	Class II	Active
Donjoy Performance	DP151KB07-BLK-M,L	FDA UDI	Class I	Active
Bell-Horn	11813XL	FDA UDI	Class I	Active
Donjoy Performance	DP151LS01-SGR-S	FDA UDI	Class I	Active
Bell-Horn	20010S	FDA UDI	Class II	Active
Donjoy Performance	DP171ES02-SGR-S	FDA UDI	Class I	Active
Donjoy Performance	DP181KS01-SGR-M	FDA UDI	Class I	Active
Compex Sport Elite	K170918	FDA 510(k)	Class II	Active
Aircast Venaflow Elite System	K122499	FDA 510(k)	Class II	Active
Vectra Neo Clinical Therapy System	K132284	FDA 510(k)	Class II	Active
Aircast Venaflow Elite System	K091700	FDA 510(k)	Class II	Active
Compex Wireless USA	K170903	FDA 510(k)	Class II	Active
Compex Sport Elite 3.0	K201653	FDA 510(k)	Class II	Active
Aircast Venaflow Elite System	K130722	FDA 510(k)	Class II	Active
Empi Phoenix	K124016	FDA 510(k)	Class II	Active
Strive	K153704	FDA 510(k)	Class II	Active
VitalStim(R) Plus Electrotherapy System	K153224	FDA 510(k)	Class II	Active
Chattanooga Revolution Wireless	K153696	FDA 510(k)	Class II	Active
Compex Wireless USA	K143551	FDA 510(k)	Class II	Active
Orthologic (tm)1000 Bone Growth Stimulator	P910066	FDA PMA	N/A	Active

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FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 19, 2026	Z-2134-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Mar 19, 2026	Z-2135-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Mar 19, 2026	Z-2136-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Mar 19, 2026	Z-2137-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Sep 25, 2025	Z-0722-2026	—	open, classified	The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
Sep 7, 2021	Z-0009-2022	—	open, classified	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Sep 7, 2021	Z-0010-2022	—	open, classified	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Jan 17, 2019	Z-1985-2019	—	open, classified	The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Jun 25, 2018	Z-2590-2020	—	terminated	The device accessories were not labeled with appropriate latex warning.
Aug 21, 2015	Z-0121-2016	—	terminated	Overheating and burning of the wire insulation inside the applicator.
May 28, 2013	Z-1661-2013	—	terminated	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).