Pelvic Binder, Inc.
Adult Yellow Pelvic Binder. Soft goods medical brace for stabilizationof fractured pelvis used by physicians in emergency room and paramedics in the pre-hospital environment.
Who Else Makes It
Concentrated in Guangdong (12), Jiangsu (12), Zhejiang (11). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Jianxing Shoe Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 11 |
| Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zhejiang Steriger Sports Medicine Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 11 |
| Ningbo NEW Nature Bath Articles Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 6 |
| Roshung International Co., Limited | Qingdao | Shandong | Contract manufacturer | 4 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
Showing 12 of 68. All 68 manufacturers in China registered for Orthosis, Truncal/Orthosis, Limb
Record
| Listed by | Pelvicbinder, Inc |
|---|---|
| FDA product code | MRI |
| Device type | Orthosis, Truncal/Orthosis, Limb |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Premarket notification | Exempt |
| Record published | 2021-12-27 |
| Record revised | 2023-01-20 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Y3000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 71 |
| ComfyHealth | Comfy Health Group Co., Ltd. | 53 |
| Ilso™ | PMT Corp. | 9 |
| Itlso™ | PMT Corp. | 9 |
| DeRoyal | Deroyal Industries, Inc. | 9 |
| Comfytopia | Comfytopia, Inc. | 8 |
| Wellbrace | Pantymed S.A. | 5 |
| WoodyKnows | M&M Pure AIR Systems LLC | 3 |
| Vive | Vive Health LLC | 3 |
| TM “Rehabilitimed” L-4M-2 Xxxl Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” L-4M-3 XL Comfort | Reabilitimed TOV | 2 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 2 |
Showing 12 of 50. All products under Orthosis, Truncal/Orthosis, 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.