Chrysalis Intelligence · Sponsors · Djo, LLC

Djo, LLC

Vista, CA, US · 1 510(k) clearances · 1 PMAs · 7 recalls (2 Class I)

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Total clearances

1

2020-11-27 → 2020-11-27

Last 12 months

0

Product codes

1

Most recent

2020-11-27

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Class II	Physical Medicine	1	2020-11-27

Class III

PMA approvals (1)

Total PMA records

1

Originals + supplements

Distinct product codes

1

First decision

2020-01-23

Most recent

2020-01-23

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2020-01-23	P910066-S031	CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)	Real-Time Process	LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic

Safety

Recalls (7)

Class I (serious)

2

Risk of injury / death

Total recalls

7

Currently ongoing

7

Most recent

2026-03-19

Date	Severity	Status	Recall #	Product	Code	Reason
2026-03-19	Class II	Ongoing	Z-2137-2026	Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Produc…	—	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19	Class II	Ongoing	Z-2136-2026	Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc…	—	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19	Class II	Ongoing	Z-2135-2026	Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Produc…	—	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19	Class II	Ongoing	Z-2134-2026	Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Desc…	—	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2025-09-25	Class II	Ongoing	Z-0722-2026	Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02	—	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 …
2021-09-07	Class I	Ongoing	Z-0010-2022	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following …	—	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Heal…
2021-09-07	Class I	Ongoing	Z-0009-2022	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO …	—	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Heal…

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2020-11-27	K201653	Compex Sport Elite 3.0	NGX	Class II	Physical Medicine