DeRoyal
Cold Therapy Unit w/knee/shoulder w/attached straps
45manufacturers in China registered for this device type
184catalogue numbers in this listing
7recalls 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 | Deroyal Industries, Inc., 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2023-12-18 (version 4) |
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 |
| Packaging | Case of 10, case of 200, box of 10, case of 72 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301C30 | In distribution | |
| T5135ST | In distribution | |
| T5035NS-L | In distribution | |
| T655NS | In distribution | |
| 302C10 | In distribution | |
| 100C51 | In distribution | |
| T5033NS | In distribution | |
| T5035NS-L-10 | In distribution | |
| 200C31 | In distribution | |
| 400C00 | In distribution | |
| T5032NS-L | In distribution | |
| T837ST | In distribution | |
| T835NSL | In distribution | |
| T530NS | In distribution | |
| T5033NS-L | In distribution | |
| 402C34 | In distribution | |
| 200C51 | In distribution | |
| T6121 | In distribution | |
| 100C70 | In distribution | |
| 100C60 | In distribution | |
| 100C90 | In distribution | |
| 200C40 | In distribution | |
| T5015ST-10 | In distribution | |
| 301C20 | In distribution | |
| 200C10 | In distribution | |
| T5075NS | In distribution | |
| T6180 | In distribution | |
| T5037ST-L | In distribution | |
| T5025NS-10 | In distribution | |
| T6100 | In distribution | |
| T5037NS-L | In distribution | |
| 301C35 | In distribution | |
| 302C37 | In distribution | |
| 302C36 | In distribution | |
| 13-700A-00 | In distribution | |
| T5060NS | In distribution | |
| 100C32 | In distribution | |
| 100C80 | In distribution | |
| 200C30 | In distribution | |
| T656NS | In distribution | |
| T5035NS | In distribution | |
| T5015NS | In distribution | |
| 301C40 | In distribution | |
| 302C50 | In distribution | |
| T836ST | In distribution | |
| 301C37 | In distribution | |
| T580NS | In distribution | |
| 402C20 | In distribution | |
| T835NS | In distribution | |
| 100C50 | In distribution | |
| T5033ST | In distribution | |
| T5030ST-10 | In distribution | |
| T5050ST | In distribution | |
| T5085ST-10 | In distribution | |
| 301C36 | In distribution | |
| T5055NS-10 | In distribution | |
| T800 | In distribution | |
| T725ST | In distribution | |
| T5085ST | In distribution | |
| T825NS | In distribution | |
| 100C53 | In distribution | |
| 100C39 | In distribution | |
| T652ST | In distribution | |
| 100C22 | In distribution | |
| 100C31 | In distribution | |
| 401C20 | In distribution | |
| T5070ST | In distribution | |
| 301C33 | In distribution | |
| T656ST | In distribution | |
| T5031NS-L | In distribution | |
| T5080NS | In distribution | |
| T735NS | In distribution | |
| T5036ST | In distribution | |
| T6110 | In distribution | |
| 100C91 | In distribution | |
| T5030ST | In distribution | |
| T5037NS-L-10 | In distribution | |
| T5055ST | In distribution | |
| T5075NS-10 | In distribution | |
| T5036ST-L-10 | In distribution | |
| T5033ST-10 | In distribution | |
| T655ST | In distribution | |
| T735NS-BULK | In distribution | |
| T5035ST-10 | In distribution | |
| T5125ST | In distribution | |
| T5075ST | In distribution | |
| T5035ST | In distribution | |
| T5055NS | In distribution | |
| 301C60 | In distribution | |
| 13-800A-00 | In distribution | |
| 302C33 | In distribution | |
| 302C31 | In distribution | |
| T5075ST-10 | In distribution | |
| T5040NS | In distribution | |
| T5035ST-L-10 | In distribution | |
| T650 | In distribution | |
| 100C71 | In distribution | |
| T5032NS-Y | In distribution | |
| T737ST | In distribution | |
| T580ST | In distribution | |
| 301C31 | In distribution | |
| T530ST | In distribution | |
| 13-809A-01 | In distribution | |
| T736NS | In distribution | |
| T735ST | In distribution | |
| T5085NS-10 | In distribution | |
| 302C20 | In distribution | |
| 301C34 | In distribution | |
| T533NS | In distribution | |
| T5031NS-XL | In distribution | |
| T5070NS | In distribution | |
| T5036NS | In distribution | |
| T725NS | In distribution | |
| T5010ST | In distribution | |
| 13-700A-00-COSM | In distribution | |
| T5015NS-10 | In distribution | |
| T736ST | In distribution | |
| T652NS | In distribution | |
| T5036ST-L | In distribution | |
| T5036NS-L | In distribution | |
| 100C11 | In distribution | |
| T5030NS | In distribution | |
| T5033NS-Y | In distribution | |
| T6190 | In distribution | |
| 13-809A-00 | In distribution | |
| T5025ST | In distribution | |
| 100C52 | In distribution | |
| T836NS | In distribution | |
| T6160 | In distribution | |
| T5037NS | In distribution | |
| T5030NS-10 | In distribution | |
| T5035ST-L | In distribution | |
| 401C30 | In distribution | |
| 200C91 | In distribution | |
| 100C54 | In distribution | |
| T5025NS | In distribution | |
| 100C30 | In distribution | |
| T5033NS-10 | In distribution | |
| T5050NS | In distribution | |
| 100C23 | In distribution | |
| T5010NS | In distribution | |
| T5055ST-10 | In distribution | |
| T837NS | In distribution | |
| T5035NS-10 | In distribution | |
| T5036NS-10 | In distribution | |
| 100C81 | In distribution | |
| T533ST | In distribution | |
| T5060ST | In distribution | |
| 100C44 | In distribution | |
| 302C30 | In distribution | |
| T5037ST-L-10 | In distribution | |
| 301C50 | In distribution | |
| T5025ST-10 | In distribution | |
| T5037ST | In distribution | |
| T600 | In distribution | |
| 302C60 | In distribution | |
| T5031ST-L | In distribution | |
| T5036ST-10 | In distribution | |
| 100C38 | In distribution | |
| 302C34 | In distribution | |
| 401C34 | In distribution | |
| T5080ST | In distribution | |
| T737NS | In distribution | |
| 301C10 | In distribution | |
| 200C90 | In distribution | |
| T6120 | In distribution | |
| T835ST | In distribution | |
| 301C32 | In distribution | |
| T825ST | In distribution | |
| T700 | In distribution | |
| T5036NS-L-10 | In distribution | |
| 200C50 | In distribution | |
| T5015ST | In distribution | |
| 302C40 | In distribution | |
| 302C32 | In distribution | |
| T5037NS-10 | In distribution | |
| T532NS | In distribution | |
| 100C10 | In distribution | |
| 302C35 | In distribution | |
| T5085NS | In distribution | |
| T505 | In distribution | |
| 402C30 | In distribution | |
| 100C33 | In distribution | |
| T5037ST-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-09-17 | Class II | Device Design | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could | 2 units | 2017-06-05 |
| 2013-09-17 | Class II | Device Design | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could | 48 units | 2017-06-05 |
| 2013-09-17 | Class II | Device Design | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could | 121 units | 2017-06-05 |
| 2013-09-17 | Class II | Device Design | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could | 409 units | 2017-06-05 |
| 2013-09-17 | Class II | Device Design | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could | 738 units | 2017-06-05 |
| 2013-09-17 | Class II | Device Design | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could | 25 units | 2017-06-05 |
| 2004-11-22 | Not classified | Other | There is a possibility of water leaking from the welded seam of the blanket. | 5084 units | 2005-09-13 |
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.