AFO Swedish, Wmns LF NAT 50/CS IF BO Suggest BLK AFO 64333
Catalogue number D64329, listed by Alimed, LLC, United States, under Orthosis, Foot Drop. 18 manufacturers in China are registered for this product code.
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 | Alimed, LLC, United States |
|---|---|
| FDA product code | OHI |
| Device type | Orthosis, Foot Drop |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2024-02-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| D64329 | 50 | 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 |
| Flint Rehab | Flint Rehabilitation Devices, 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 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.