Hi-Fortune
Weight: 7.8kg, L570mm*W390mm*H985mm
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (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 |
|---|---|---|---|---|
| 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 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Zhejiang Xinhao Rehabilitation Equipment Co., Ltd. | Anji County | Zhejiang | Contract manufacturer | 4 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Kunshan Hi-Fortune Health Products Co., Ltd., China |
|---|---|
| FDA product code | KNL |
| Device type | Board, Scooter, Prone |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5370 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-10-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HR-111-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Large Prone Stander | Rifton Equipment | 1 |
| Mini Mobile Stander | Rifton Equipment | 1 |
| Medium Prone Stander | Rifton Equipment | 1 |
| Medium Mobile Stander | Rifton Equipment | 1 |
| Small Mobile Stander | Rifton Equipment | 1 |
| Large Mobile Stander | Rifton Equipment | 1 |
| Small Prone Stander | Rifton Equipment | 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.