DeRoyal
Bucks Traction Boot
27manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | HSP |
| Device type | Splint, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TX9909-00 | In distribution | |
| 19404 | In distribution | |
| 698P10 | In distribution | |
| 8121-00 | In distribution | |
| A155007 | In distribution | |
| 605P10 | In distribution | |
| 606P10 | In distribution | |
| 8106-04 | In distribution | |
| 8112-00 | In distribution | |
| 600P10 | In distribution | |
| 8144-00 | In distribution | |
| 8105-05 | In distribution | |
| 19403 | In distribution | |
| 8105-02 | In distribution | |
| 603P10 | In distribution | |
| 19402 | In distribution | |
| 8105-06 | In distribution | |
| 8105-01 | In distribution | |
| 8105-04 | In distribution | |
| 8106-01 | In distribution | |
| A155006 | In distribution | |
| 27102 | In distribution | |
| 8108-05 | In distribution | |
| 8105-03 | In distribution | |
| 8140-00 | In distribution | |
| 27101 | In distribution | |
| 19406 | In distribution | |
| 8106-06 | In distribution | |
| A155008 | In distribution | |
| 604P10 | In distribution | |
| 8120-00 | In distribution | |
| 8108-06 | In distribution | |
| 19405 | In distribution | |
| 8108-04 | In distribution | |
| 8106-03 | In distribution | |
| 8108-03 | In distribution | |
| 8130-00 | In distribution | |
| 8106-05 | In distribution | |
| 8143-00 | In distribution | |
| A155005 | In distribution | |
| A150000 | In distribution | |
| 19401 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| E.M Adams Co., Inc. | E.M. Adams Co., 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.