Invacare Essentials Rollator
Rollator, Essentials, Collapsible, Blue, Strap, Adjustable Arms and Legs
183manufacturers in China registered for this device type
2catalogue numbers in this listing
2recalls on this code
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 | Invacare GmbH, Germany |
|---|---|
| FDA product code | ITJ |
| Device type | Walker, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3825 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESS-ROLL01 | In distribution | |
| ESS-ROLL02 | In distribution |
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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-06-15 | Class II | Device Design | Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device’s seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user | 586 devices | |
| 2011-03-02 | Not classified | Device Design | The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Cons | 12,764 walkers were distributed. | 2013-07-02 |
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.