Kaye Products – R2BSX
Youth Posture Control Walker/Gait Trainer/ Wide Version W2B/ Front Swivel/Silent Rear
183manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (73), Jiangsu (38), Zhejiang (32). 19 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 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Zhenjiang Assure Medical Equipment Co Ltd | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Genteel Homecare Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 12 |
| Jiaxing Xinyi Medical Instrument Co., Ltd. | Jiashan | Zhejiang | Contract manufacturer | 12 |
Showing 12 of 183. All 183 manufacturers in China registered for Walker, Mechanical
Record
| Listed by | Kaye Products, Inc., United States |
|---|---|
| FDA product code | ITJ |
| Device type | Walker, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3825 |
| Premarket notification | Exempt |
| Record published | 2023-07-05 |
| Record revised | 2025-05-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Distribution end date | 2025-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R2BSX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drive | Drive DeVilbiss Healthcare | 202 |
| Drivemedical | Drive DeVilbiss Healthcare | 154 |
| Walker | Zhongshan Sunneo Medical Instruments Co., Ltd. | 110 |
| Homland | Hongkong Pishon Medical Equipment Co., Limited | 76 |
| Grillo | Ormesa SRL | 68 |
| Vive Mobility | Vive Health LLC | 63 |
| Probasics | Drive DeVilbiss Healthcare | 57 |
| R82 | R82 A/S | 25 |
| Bradacare | Bradacare (Xiamen) Health Technology Co., Ltd. | 22 |
| Vocic | Zhejiang Mateside Medical Devices Technology Co., Ltd. | 21 |
| Soundfuse | Hongkong Pishon Medical Equipment Co., Limited | 20 |
| Hugo | Drive DeVilbiss Healthcare | 20 |
Showing 12 of 227. All products under Walker, Mechanical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K833869 | 1983-11-29 |
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.