Performance Health
Rolyan Shoulder Immobilizer, X-Small
13manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Hubei (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Aimmax Medical Products Co., Ltd. | Shiyan | Hubei | Contract manufacturer | 10 |
| Jiangyin Puremed | Jiangyin | Jiangsu | Contract manufacturer | 7 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Brady (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 1 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Shaoxing Songqiao Textile Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 26 |
| Dongguan City Fenglinwan Leisure Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Ellian Enterprise, Ltd. | Dongguan | Guangdong | Contract manufacturer | 10 |
| Jiangyin Huaying Light Industrial Products Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 13. All 13 manufacturers in China registered for Board, Arm (With Cover), Non-Sterile
Record
| Listed by | ASP Global, LLC, United States |
|---|---|
| FDA product code | NOD |
| Device type | Board, Arm (With Cover), Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-24 |
| Record revised | 2023-05-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Distribution end date | 2023-05-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A545803 | In distribution | |
| A545801 | In distribution | |
| A545802 | In distribution | |
| A545804 | In distribution | |
| A545800 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MTI | Tech Industries. Inc. | 307 |
| Morrison Medical | Morrison Corporation | 82 |
| Board, Arm (With Cover), Non-Sterile | MID Central Medical | 20 |
| Soule Medical | Soule Co., THE | 14 |
| Pedi Board | Pedicraft, Inc. | 7 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 7 |
| Sharn Inc | Sharn Anesthesia | 3 |
| Pinestar Technology Inc | Pinestar Technology Inc. | 3 |
| ACS Disposable 30/CS | Alimed, LLC | 1 |
| Voss Convoluted Arm Board | VM/Positioning, Inc. | 1 |
| Image Diagnostics, Inc. | Image Diagnostics, Inc. | 1 |
| ACS W/ Strap (12/CS) | Alimed, LLC | 1 |
Showing 12 of 14. All products under Board, Arm (With Cover), Non-Sterile
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.