Youwen
12L cold therapy machine/system/set/unit with universal pad
45manufacturers in China registered for this device type
55catalogue numbers in this listing
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 | Shanghai Youwen Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | ILO |
| Device type | Pack, Hot Or Cold, Water Circulating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5720 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5L (blue) | In distribution | |
| 12L (turquoise)+ knee+CPC | In distribution | |
| black universal | In distribution | |
| blue universal | In distribution | |
| black ankle | In distribution | |
| black head | In distribution | |
| black knee 3.0 | In distribution | |
| blue elbow | In distribution | |
| knee blue+CPC | In distribution | |
| black hand | In distribution | |
| blue ankle | In distribution | |
| blue shoulder 3.0 | In distribution | |
| 12L (turquoise)+ shoulder+CPC | In distribution | |
| 6L (black)V1 | In distribution | |
| 5L (black) | In distribution | |
| blue face | In distribution | |
| disposable face 2.0 | In distribution | |
| 12L (black) | In distribution | |
| 12L (blue)+universal | In distribution | |
| blue waist | In distribution | |
| blue thigh | In distribution | |
| blue face 2.0 | In distribution | |
| black knee | In distribution | |
| shoulder blue+CPC | In distribution | |
| black elbow | In distribution | |
| blue universal 2.0 | In distribution | |
| disposable head | In distribution | |
| blue blanket 2.0 | In distribution | |
| blue hip | In distribution | |
| hip blue+CPC | In distribution | |
| disposable face | In distribution | |
| black thigh | In distribution | |
| 5L (blue)+universal | In distribution | |
| black shoulder | In distribution | |
| blue hand | In distribution | |
| blue face 3.0 | In distribution | |
| black universal 2.0 | In distribution | |
| blue knee 3.0 | In distribution | |
| 12L (turquoise )+CPC | In distribution | |
| black blanket | In distribution | |
| black face | In distribution | |
| black blanket 2.0 | In distribution | |
| black shoulder 3.0 | In distribution | |
| blue head | In distribution | |
| blue blanket | In distribution | |
| black face 3.0 | In distribution | |
| black face 2.0 | In distribution | |
| 12L (blue) | In distribution | |
| blue knee | In distribution | |
| disposable face 3.0 | In distribution | |
| black hip | In distribution | |
| blue shoulder | In distribution | |
| 12L (turquoise)+ hip+CPC | In distribution | |
| 6L (blue) V2 | In distribution | |
| black waist | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 184 |
| Breg | Breg, Inc. | 135 |
| Game Ready | Avanos Medical, Inc. | 101 |
| Donjoy | DJO, LLC | 72 |
| CTC-7 | Daesung Maref Co., Ltd. | 67 |
| Aircast | DJO, LLC | 63 |
| 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
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.