Flint Rehab
Flex AFO
18manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (8), Hebei (3), Zhejiang (3). 5 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 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Skytech Electronics (HK) Limited | Tsim Sha Tsui | Hong Kong | Contract manufacturer | 5 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Hengshui Jingkang Medical Device Co., Ltd. | Hengshui | Hebei | Manufacturer | 31 |
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen | Fujian | Repacker / relabeller | 24 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
| Hangzhou Yunchi Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
Showing 12 of 18. All 18 manufacturers in China registered for Orthosis, Foot Drop
Record
| Listed by | Flint Rehabilitation Devices, LLC, United States |
|---|---|
| FDA product code | OHI |
| Device type | Orthosis, Foot Drop |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AFO | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ViveSole | Vive Health LLC | 22 |
| PeroSupport.tec | Streifeneder ortho.production gmbH | 18 |
| Vive | Vive Health LLC | 15 |
| Maramed Orthopedic Systems | Biosculptor Corporation | 8 |
| AFO Swedish: Mens RT NAT 50/CS IF BO Suggest BLK AFO 64334 | Alimed, LLC | 1 |
| Easy Step | M.a.s.s. Rehab, LLC | 1 |
| AFO Swedish, Wmns RT NAT 50/CS IF BO Suggest BLK AFO 64332 | Alimed, LLC | 1 |
| AFO Swedish, Wmns LF NAT 50/CS IF BO Suggest BLK AFO 64333 | Alimed, LLC | 1 |
| AFO C-50 LG/RT WM10-11 MN9-12 | Alimed, LLC | 1 |
| Padding Set for PeroSupport.tec | Streifeneder ortho.production gmbH | 1 |
| AFO Swedish, Mens LF NAT 50/C IF BO Suggest BLK AFO 64335 | Alimed, LLC | 1 |
| Multiboot Regular | Alimed, LLC | 1 |
Showing 12 of 13. All products under Orthosis, Foot Drop
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.