Plastalume
Stax-Mallets
6manufacturers in China registered for this device type
25catalogue 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 | Brownmed, United States |
|---|---|
| FDA product code | FYH |
| Device type | Splint, Extremity, Noninflatable, External, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-14 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10702 | In distribution | |
| 10626 | In distribution | |
| 10708 | In distribution | |
| 10622 | In distribution | |
| 10671 | In distribution | |
| 10652 | In distribution | |
| 10624 | In distribution | |
| 10737 | In distribution | |
| 10706 | In distribution | |
| 10621 | In distribution | |
| 10641 | In distribution | |
| 10672 | In distribution | |
| 10662 | In distribution | |
| 10701 | In distribution | |
| 10682 | In distribution | |
| 10731 | In distribution | |
| 10707 | In distribution | |
| 10681 | In distribution | |
| 10704 | In distribution | |
| 10705 | In distribution | |
| 10661 | In distribution | |
| 10632 | In distribution | |
| 10730 | In distribution | |
| 10642 | In distribution | |
| 10623 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nice Stretch | Brownmed | 19 |
| Jelco | ICU Medical, Inc | 10 |
| SC | Allied Medical LLC | 9 |
| 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.