E-Fix®
56 catalogue numbers from E35 eco, listed by Alber Gmbh, Germany, under Wheelchair, Powered. 62 manufacturers in China are registered for this product code.
62manufacturers in China registered for this device type
56catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (14), Guangdong (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| 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 |
| Viscount HI-Tech (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
| Zhejiang Linix Motor Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 4 |
| Jiangsu Bangbang Intelligent Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 2 |
| Jinhua Ruidi Vehicle Industry Co Ltd | Zhejiang | Zhejiang | Contract manufacturer | 2 |
| Suzhou Green Pine Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Zhenjiang Assure Medical Equipment Co Ltd | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 62. All 62 manufacturers in China registered for Wheelchair, Powered
Record
| Listed by | Alber Gmbh, Germany |
|---|---|
| FDA product code | ITI |
| Device type | Wheelchair, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3860 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161241 |
| Record published | 2021-12-16 |
| Record revised | 2026-05-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E25 | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E35/E36 | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution | |
| E25 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35/E36 | In distribution | |
| E35 eco | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merits | Merits Health Products, Inc. | 186 |
| e-motion® | Alber Gmbh | 129 |
| Modular Power Positioning System | Motion Concepts | 112 |
| TRZ-CG Power Positioning System | Motion Concepts | 54 |
| Batec | Batec Mobility SL. | 48 |
| Drive | Drive DeVilbiss Healthcare | 47 |
| Invacare® TDX® Power Wheelchair | Invacare GmbH | 43 |
| Drivemedical | Drive DeVilbiss Healthcare | 34 |
| Heartway Medical Products Co., Ltd. | Heartway Medical Products Co., Ltd. | 20 |
| Scout | Burke, Inc. | 20 |
| Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 18 |
| twion® | Alber Gmbh | 18 |
Showing 12 of 277. All products under Wheelchair, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221215 | 2022-05-24 |
| K192618 | 2020-11-02 |
| K192016 | 2020-05-19 |
| K161241 | 2016-10-05 |
| K151717 | 2016-02-23 |
| K943789 | 1994-11-08 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Frank Mobility Systems, Inc. | 510(k) number | 2004-08-01 | Not classified | Other | may short circuit within the interface due to long term exposure of liquid | 314 units | 2006-08-23 |
| Frank Mobility Systems, Inc. | 510(k) number | 2004-08-01 | Not classified | Other | may short circuit within the interface due to long term exposure of liquid | 314 units | 2006-08-23 |
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.