Game Ready
Shoulder Wrap* with ATX, Medium, Right (fits chest sizes 33"-45")
45manufacturers in China registered for this device type
101catalogue 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 | Avanos Medical, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K192114 |
| Record published | 2016-08-12 |
| Record revised | 2023-12-18 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 520811-03 | In distribution | |
| 303528 | In distribution | |
| 590920-03 | In distribution | |
| 510920 | In distribution | |
| 303677 | In distribution | |
| 520915-03 | In distribution | |
| 590811-03 | In distribution | |
| 570302 | In distribution | |
| 303660 | In distribution | |
| 590422-03 | In distribution | |
| 520912-03 | In distribution | |
| 590160-03-RN | In distribution | |
| 510922 | In distribution | |
| 520602-03 | In distribution | |
| 520200-03 | In distribution | |
| 510502 | In distribution | |
| 550500-03-RF | In distribution | |
| 510602 | In distribution | |
| 510200 | In distribution | |
| 510916 | In distribution | |
| 510422 | In distribution | |
| 590340-03 | In distribution | |
| 570304 | In distribution | |
| 590422-03-RN | In distribution | |
| 520424-03 | In distribution | |
| 590432-03-RN | In distribution | |
| 590906-03 | In distribution | |
| 520340-03 | In distribution | |
| 520160-03 | In distribution | |
| 510340 | In distribution | |
| 520903-03 | In distribution | |
| 590200-03 | In distribution | |
| 303640 | In distribution | |
| 520918-03 | In distribution | |
| 590602-03 | In distribution | |
| 520500-03 | In distribution | |
| 590100-03 | In distribution | |
| 510923 | In distribution | |
| 510100 | In distribution | |
| 510330 | In distribution | |
| 590604-03 | In distribution | |
| 573224 | In distribution | |
| 570300 | In distribution | |
| 510434 | In distribution | |
| 590916-03 | In distribution | |
| 570324 | In distribution | |
| 303662 | In distribution | |
| 590424-03 | In distribution | |
| 550500-53 | In distribution | |
| 552724 | In distribution | |
| 503580 | In distribution | |
| 520100-03 | In distribution | |
| 550500-93 | In distribution | |
| 610200-03 | In distribution | |
| 503565 | In distribution | |
| 503532 | In distribution | |
| 510918 | In distribution | |
| 520920-03 | In distribution | |
| 510906 | In distribution | |
| 520422-03 | In distribution | |
| 303022 | In distribution | |
| 590502-03 | In distribution | |
| 590434-03 | In distribution | |
| 550500-83 | In distribution | |
| 573197 | In distribution | |
| 590915-03 | In distribution | |
| 520330-03 | In distribution | |
| 590434-03-RN | In distribution | |
| 520922-03 | In distribution | |
| 630200-03 | In distribution | |
| 510903 | In distribution | |
| 510500 | In distribution | |
| 510915 | In distribution | |
| 590330-03 | In distribution | |
| 590903-03 | In distribution | |
| 510604 | In distribution | |
| 590912-03 | In distribution | |
| 510424 | In distribution | |
| 510160 | In distribution | |
| 303801 | In distribution | |
| 573226 | In distribution | |
| 503582 | In distribution | |
| 520502-03 | In distribution | |
| 550500-03 | In distribution | |
| 550500-63 | In distribution | |
| 520604-03 | In distribution | |
| 552723 | In distribution | |
| 590918-03 | In distribution | |
| 590160-03 | In distribution | |
| 520923-03 | In distribution | |
| 510811 | In distribution | |
| 303529 | In distribution | |
| 520906-03 | In distribution | |
| 590500-03 | In distribution | |
| 590432-03 | In distribution | |
| 510432 | In distribution | |
| 303661 | In distribution | |
| 550500-13 | In distribution | |
| 510912 | In distribution | |
| 520916-03 | In distribution | |
| 303659 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 184 |
| Breg | Breg, Inc. | 135 |
| 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
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.