Sling, Knee, Kodel
Catalogue number 334, listed by Mizuho Orthopedic Systems, Inc., United States, under Splint, Traction. 27 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (8), Jiangsu (7), Guangdong (5). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
Showing 12 of 27. All 27 manufacturers in China registered for Splint, Traction
Record
| Listed by | Mizuho Orthopedic Systems, Inc., United States |
|---|---|
| FDA product code | HSP |
| Device type | Splint, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 334 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 42 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 31 |
| Rhino Rescue | Wuxi Emsrun Technology Co., Ltd. | 17 |
| Senolo | Jiangsu Senolo Medical Technology Co., Ltd. | 11 |
| CT-6 Traction Splint | Faretec, Inc. | 8 |
| Rhino Rescue | Emsrun Group | 7 |
| Implate | Skeletal Dynamics L.L.C. | 6 |
| CT-7 Traction Splint | Faretec, Inc. | 6 |
| QD-3 Traction Splint | Faretec, Inc. | 2 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2 |
| Lightning X Products,Inc | Wuxi Emsrun Technology Co., Ltd. | 2 |
| Tiii Traction Splint | Faretec, Inc. | 2 |
Showing 12 of 29. All products under Splint, Traction
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.