Lower Limb Orthotics
2 catalogue numbers from Knee Orthosis (KO), listed by Boston Brace International, Incorporated, United States, under Orthosis, Limb Brace. 144 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (46), Zhejiang (25), Jiangsu (20). 32 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Suzhou Sunmed Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 28 |
| 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 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
Showing 12 of 144. All 144 manufacturers in China registered for Orthosis, Limb Brace
Record
| Listed by | Boston Brace International, Incorporated, United States |
|---|---|
| FDA product code | IQI |
| Device type | Orthosis, Limb Brace |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| 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 |
|---|---|---|
| Knee Orthosis (KO) | In distribution | |
| Knee Ankle Foot Orthosis (KAFO) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 984 |
| DeRoyal | Deroyal Industries, Inc. | 295 |
| Thrive Orthopedics | Thrive Orthopedics | 272 |
| Formthotics | Foot Science International, Ltd. | 254 |
| VQ Orthocare | Vision Quest Industries, Inc. | 156 |
| Donjoy Performance | DJO, LLC | 78 |
| Profit | Pantymed S.A. | 73 |
| Procare | DJO, LLC | 63 |
| PediHip | Orthopediatrics, Corp | 60 |
| ComfyHealth | Comfy Health Group Co., Ltd. | 51 |
| Push braces | Nea International B.V. | 48 |
| Soft Stride | Brownmed | 44 |
Showing 12 of 664. All products under Orthosis, Limb Brace
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.