DeRoyal
Wheelchair Belt, Torso Support
15manufacturers in China registered for this device type
10catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (4), Guangdong (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Chiaphua Components (Jiangxi) Limited | Yichun | Jiangxi | Contract manufacturer | 23 |
| Feishen Group Co., Ltd. | Yongkang | Zhejiang | Contract manufacturer | 22 |
| Guangdong Marshell Electric Vehicle Co., Ltd. | Zhaoqing | Guangdong | Contract manufacturer | 22 |
| Zhenjiang Assure Medical Equipment Co Ltd | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| China Wonderland Nurserygoods Co., Ltd. | Dongguan | Guangdong | Manufacturer | 18 |
| Jiangsu Assure Medical Equipment Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 15. All 15 manufacturers in China registered for Restraint, Wheelchair, Non-Protective
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | KID |
| Device type | Restraint, Wheelchair, Non-Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3910 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-03 |
| Record revised | 2023-10-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M5162-M | In distribution | |
| M5150 | In distribution | |
| M5210 | In distribution | |
| M2815D01 | In distribution | |
| M5165D-U | In distribution | |
| M5210S | In distribution | |
| M5162-L | In distribution | |
| M5147 | In distribution | |
| M5162-S | In distribution | |
| M5160D-U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 18 |
| Salvaclip | Medi Care System SLU | 18 |
| Salvaclip Comfort | Medi Care System SLU | 17 |
| Valmax | Supply Line International Medical, LLC | 2 |
| Small Right Arm Anchor | Rifton Equipment | 1 |
| Horizontal Anchor | Rifton Equipment | 1 |
| Small Left Arm Anchor | Rifton Equipment | 1 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 1 |
| Grab Bar | Rifton Equipment | 1 |
| Large Left Arm Anchor | Rifton Equipment | 1 |
| Large Right Arm Anchor | Rifton Equipment | 1 |
| Left Elbow Anchor | Rifton Equipment | 1 |
Showing 12 of 15. All products under Restraint, Wheelchair, Non-Protective
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963479 | 1997-01-24 |
| K963475 | 1997-01-22 |
| K963480 | 1997-01-22 |
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.