Lower Limb Orthotics
2 catalogue numbers from Reciprocating Gait Orthosis (RGO), listed by Boston Brace International, Incorporated, United States, under Orthosis, Truncal/Orthosis, Limb. 68 manufacturers in China are registered for this product code.
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 | Boston Brace International, Incorporated, United States |
|---|---|
| FDA product code | MRI |
| Device type | Orthosis, Truncal/Orthosis, Limb |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-11 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Reciprocating Gait Orthosis (RGO) | In distribution | |
| Hip Knee Ankle Foot Orthosis (HKAFO) | 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.