Boston Brace
Soft Body Jacket-single open- finished
110manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (35), Jiangsu (18), Zhejiang (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Shenzhen City U-Lucky Sporting Goods Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Tops Medical Articles Industries Nantong Inc | Qidong | Jiangsu | Contract manufacturer | 17 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Zhejiang Steriger Sports Medicine Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 11 |
| Fenglin Industry Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 10 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
Showing 12 of 110. All 110 manufacturers in China registered for Orthosis, Lumbar
Record
| Listed by | Boston Brace International, Incorporated, United States |
|---|---|
| FDA product code | IQE |
| Device type | Orthosis, Lumbar |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-30 |
| Record revised | 2024-07-25 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Scoliosis: Boston 3D-Finished Boston | In distribution | |
| Boston Brace Baby | In distribution | |
| Scoliosis: Boston Scoli-NightShift | In distribution | |
| Boston Brace RC | In distribution | |
| Boston Brace Original | In distribution | |
| Scoliosis: Boston Scoli-Finish-Kyhosis -cowhorns | In distribution | |
| Scoliosis: Soft Body Jacket: Boston Scoli | In distribution | |
| Soft Body Jacket | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 118 |
| Neotech Care | Neotech Care Inc. | 84 |
| Curble Chair | Ablue Co., Ltd. | 42 |
| Copperfit | Ideavillage Products Corp. | 34 |
| Vive | Vive Health LLC | 30 |
| Best Back | Indaco SRL | 28 |
| M-Brace Air | Indaco SRL | 24 |
| Breg | Breg, Inc. | 18 |
| CoreTech | Vive Health LLC | 17 |
| Push braces | Nea International B.V. | 12 |
| Tairuibosi | Tianjin Tairuibosi Medical Appliance Co., Ltd. | 9 |
| Guardian Supporter | BM Korea Co., Ltd. | 8 |
Showing 12 of 67. All products under Orthosis, Lumbar
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.