Dale Bendable Armboard
Dale Bendable Armboard, Medium, 5.38" x 2.5"
6manufacturers in China registered for this device type
8catalogue 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 | Dale Medical Products, Inc., United States |
|---|---|
| FDA product code | FYH |
| Device type | Splint, Extremity, Noninflatable, External, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-04 |
| Record revised | 2024-04-22 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 651 | In distribution | |
| 650 | In distribution | |
| 652 | In distribution | |
| 650 | In distribution | |
| 651 | In distribution | |
| 653 | In distribution | |
| 653 | In distribution | |
| 652 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plastalume | Brownmed | 25 |
| Nice Stretch | Brownmed | 19 |
| Jelco | ICU Medical, Inc | 10 |
| SC | Allied Medical LLC | 9 |
| 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.