Donjoy
Iceman CLEAR3 W/ Universal Cold PAD, NS, RH, Ortho Rhode IS
45manufacturers in China registered for this device type
72catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (17), Zhejiang (6), Fujian (5). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Wealthy Plastic & Electronic Products Company Limited | Huizhou | Guangdong | Contract manufacturer | 6 |
| Chengdu Cryo-Push Medical Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 4 |
| Zhejiang E-Cozy Electronic Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
Showing 12 of 45. All 45 manufacturers in China registered for Pack, Hot Or Cold, Water Circulating
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | ILO |
| Device type | Pack, Hot Or Cold, Water Circulating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2023-12-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-03-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-1424 | In distribution | |
| 11-1631-0429 | In distribution | |
| 11-0675-9-00000 | In distribution | |
| 11-0676-9-00000 | In distribution | |
| 11-1316-0-02000 | In distribution | |
| 11-1635 | In distribution | |
| 11-0802-9-00000 | In distribution | |
| 11-0804-9-00000 | XL | In distribution |
| 11-0681-9-00000 | XL | In distribution |
| 11-0680-9-00000 | In distribution | |
| 11-0677-9-00000 | XL | In distribution |
| 11-0674-9-02000 | In distribution | |
| 11-1636 | In distribution | |
| 11-0493-1978 | In distribution | |
| 11-1397-9-00000 | In distribution | |
| 11-1334-9-00000 | In distribution | |
| 11-1439 | In distribution | |
| 11-1629 | In distribution | |
| 11-1629-1978 | In distribution | |
| 11-1522 | N/A | In distribution |
| 11-1631-0546 | In distribution | |
| 11-1269-9-00000 | In distribution | |
| 11-0610-9-00000 | In distribution | |
| 11-0493 | In distribution | |
| 11-1423 | In distribution | |
| 11-1425 | In distribution | |
| 11-1315-0-02000 | In distribution | |
| 11-1631-1978 | In distribution | |
| 11-1268-9-00000 | In distribution | |
| 11-1631 | In distribution | |
| 11-0679-9-00000 | L | In distribution |
| 11-1521 | In distribution | |
| 11-1636-1978 | In distribution | |
| 11-1633 | In distribution | |
| 11-1426 | In distribution | |
| 11-9112 | N/A | In distribution |
| 11-0493-0753 | In distribution | |
| 11-1630 | In distribution | |
| 11-1630-1978 | In distribution | |
| 11-1438 | In distribution | |
| 11-1422-9 | In distribution | |
| 3-0494 | In distribution | |
| 11-0614-9-00000 | L-XL | In distribution |
| 11-1640 | In distribution | |
| 11-1422 | In distribution | |
| 11-9099 | In distribution | |
| 11-1638-1978 | In distribution | |
| 11-1421 | In distribution | |
| 11-0817-9-00000 | In distribution | |
| 11-0493-0429 | N/A | In distribution |
| 11-0813-9-00000 | XL | In distribution |
| 11-0611-9-00000 | S-M | In distribution |
| 11-0801-9-00000 | In distribution | |
| 11-1459 | In distribution | |
| 11-1631-8485 | In distribution | |
| 11-9098 | UNIV | In distribution |
| 11-0815-9-00000 | In distribution | |
| 11-9111 | N/A | In distribution |
| 11-0678-9-00000 | XL | In distribution |
| 11-0682-9-00000 | XL | In distribution |
| 11-0612-9-00000 | L-XL | In distribution |
| 11-0494 | In distribution | |
| 11-1635-1978 | In distribution | |
| 11-1633-1978 | In distribution | |
| 11-1631-0824 | In distribution | |
| 11-1638 | In distribution | |
| 11-1360-9-00000 | In distribution | |
| 11-3334 | In distribution | |
| 11-1318-0-02000 | In distribution | |
| 11-0746 | Withdrawn | |
| 11-1317-0-02000 | Withdrawn | |
| 11-1446 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 184 |
| Breg | Breg, Inc. | 135 |
| Game Ready | Avanos Medical, Inc. | 101 |
| CTC-7 | Daesung Maref Co., Ltd. | 67 |
| Aircast | DJO, LLC | 63 |
| Youwen | Shanghai Youwen Medical Technology Co., Ltd. | 55 |
| Soft-Temp | Adroit Medical Systems, Inc. | 36 |
| ThermaZone | Innovative Medical Equipment | 27 |
| Cold Rush | Ossur Americas | 22 |
| Med4 Elite | Avanos Medical, Inc. | 20 |
| Cryopush | Chengdu Cryo-Push Medical Technology Co., Ltd. | 18 |
| Polar Products | Polar Products Inc | 18 |
Showing 12 of 153. All products under Pack, Hot Or Cold, Water Circulating
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| DJO, LLC | UDI-DI | 2026-03-19 | Class II | Process control | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 596 |
| DJO, LLC | UDI-DI | 2026-03-19 | Class II | Process control | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 1412 |
| DJO, LLC | UDI-DI | 2026-03-19 | Class II | Process control | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 480 |
| DJO, LLC | UDI-DI | 2026-03-19 | Class II | Process control | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | 96 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.