Cover, Limb
Wrist Cover
24manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (10), Guangdong (5), Hebei (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Dongguan Sava Sporting Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Zhejiang Qiangnao Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 2 |
| Shaoxing Annor Textile Company Limited | Shaoxing | Zhejiang | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
Showing 12 of 24. All 24 manufacturers in China registered for Cover, Limb
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | IPM |
| Device type | Cover, Limb |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2022-05-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 394.052 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 360 |
| Juzo Dynamic | Julius Zorn, Inc. | 238 |
| Coolmax Sock | Alps South LLC | 180 |
| DeRoyal | Deroyal Industries, Inc. | 133 |
| Tex-Care Medical | Flynt Amtex, Inc. | 128 |
| Coolblue Sock | Alps South LLC | 101 |
| Juzo Dynamic Xtra | Julius Zorn, Inc. | 90 |
| Juzo Dynamic Silver | Julius Zorn, Inc. | 90 |
| Genesee | College Park Industries | 89 |
| Sterling | College Park Industries | 77 |
| Silicone Glove | Hugh Steeper Ltd | 50 |
| PVC Glove | Hugh Steeper Ltd | 36 |
Showing 12 of 173. All products under Cover, Limb
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.