SC
Adult Foot AND Ankle Splint
6manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Hangzhou GspMed Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Anertai Industrial Limited | Dongguan | Guangdong | Exporter | 12 |
Record
| Listed by | Allied Medical LLC, United States |
|---|---|
| FDA product code | FYH |
| Device type | Splint, Extremity, Noninflatable, External, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-09 |
| Record revised | 2025-10-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S500 | In distribution | |
| S530 | In distribution | |
| S501 | In distribution | |
| S511 | In distribution | |
| S502 | In distribution | |
| S512 | In distribution | |
| S520 | In distribution | |
| S504 | In distribution | |
| S503 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plastalume | Brownmed | 25 |
| Nice Stretch | Brownmed | 19 |
| Jelco | ICU Medical, Inc | 10 |
| Dale Bendable Armboard | Dale Medical Products, Inc. | 8 |
| Inro Surgical Nail | Inro Medical Designs, Inc. | 1 |
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.