DeRoyal
Elbow Brace
6manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Jiangsu (1). 2 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 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Huzhou Universal Glove Company Limited | Huzhou | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IRD |
| Device type | Joint, Elbow, External Limb Component, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-29 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6003-01 | In distribution | |
| 6003-03 | In distribution | |
| 6003-04 | In distribution | |
| 6003-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Espire | Hugh Steeper Ltd | 36 |
| Elbow | Hugh Steeper Ltd | 30 |
| Copperfit | Ideavillage Products Corp. | 17 |
| Control and Suspension Systems | Hugh Steeper Ltd | 16 |
| Automatic Elbow | Hugh Steeper Ltd | 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.