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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. Device Description:…
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. Device Description: Front and rear 8-inch solid wheels, acid batteries,black and red color of the scooter shell,with headlight.
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (9), Guangdong (8). 10 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 |
| Zhejiang Linix Motor Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 4 |
| Jinhua Ruidi Vehicle Industry Co Ltd | Zhejiang | Zhejiang | Contract manufacturer | 2 |
| Suzhou Green Pine Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Dongguan Tetro Ltd (China) | Dongguan | Guangdong | Contract manufacturer | 1 |
| Guangdong Zhanyuan Smart Science and Technology Co., Ltd. | Dalang Town, Dongguan | Guangdong | Contract manufacturer | 1 |
| Shanghai Chien TI Motor Co., Ltd. | Jia Ding Dist. | Shanghai | Contract manufacturer | 1 |
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
Showing 12 of 41. All 41 manufacturers in China registered for Vehicle, Motorized 3-Wheeled
Record
| Listed by | Wal Mart Stores, Inc |
|---|---|
| FDA product code | INI |
| Device type | Vehicle, Motorized 3-Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3800 |
| 510(k) | K062645 |
| Record published | 2022-06-18 |
| Record revised | 2024-07-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| Sizes | Weight 48 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| W3431D | Weight 48 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merits | Merits Health Products, Inc. | 58 |
| Drive | Drive DeVilbiss Healthcare | 38 |
| Drivemedical | Drive DeVilbiss Healthcare | 38 |
| Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 33 |
| Freerider | Freerider, Corp. | 23 |
| Shoprider | Pihsiang Machinery Manufacturing Co., Ltd. | 17 |
| Heartway Medical Products Co., Ltd. | Heartway Medical Products Co., Ltd. | 16 |
| CTM Mobility Scooter | C.T.M. Homecare Product, Inc. | 14 |
| Pacesaver | Burke, Inc. | 14 |
| CTM | Chien TI Enterprise Co., Ltd. | 13 |
| Scout | Drive DeVilbiss Healthcare | 12 |
| Vive Mobility | Vive Health LLC | 12 |
Showing 12 of 149. All products under Vehicle, Motorized 3-Wheeled
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.