Merits
Roadster S3 Three Wheel Scooter - Blue, With Batteries
41manufacturers in China registered for this device type
58catalogue numbers in this listing
7510(k) clearances naming this product code
1recall
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 | Merits Health Products, Inc., United States |
|---|---|
| FDA product code | INI |
| Device type | Vehicle, Motorized 3-Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K011707 |
| Record published | 2016-09-12 |
| Record revised | 2023-04-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2030-09-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S740-1ARMUB | In distribution | |
| S13152SBMU | In distribution | |
| S14152ARMUB | In distribution | |
| S941L-SDMU | In distribution | |
| S14151ARMUB | In distribution | |
| S341-1ARMUB | In distribution | |
| S746-1ARMUB | In distribution | |
| S741RS4-SBB | In distribution | |
| S740–WRMUB | In distribution | |
| S13152SBMUB | In distribution | |
| S1315-SBMU | In distribution | |
| S131–ARMU | In distribution | |
| S539–ARMUB | In distribution | |
| S549–ARMUB | In distribution | |
| S1415-SBMU | In distribution | |
| S2354-SBMUB | In distribution | |
| S341-1ARMU | In distribution | |
| S731B-SBMUB | In distribution | |
| S549–SBMUB | In distribution | |
| S2454-ARMUB | In distribution | |
| S941A1SVMU | In distribution | |
| S2354-ARMUB | In distribution | |
| S730–ARMUB | In distribution | |
| S746–ARMUB | In distribution | |
| S542–YLMUB | In distribution | |
| S731B-ARMUB | In distribution | |
| S1415-ARMU | In distribution | |
| S14152ARMU | In distribution | |
| S731–ARMUB | In distribution | |
| S13152ARMU | In distribution | |
| S1315-ARMU | In distribution | |
| S731A-ARMUB | In distribution | |
| S2454-SBMUB | In distribution | |
| S941L-SDMUB | In distribution | |
| S331-1ARMU | In distribution | |
| S13151ARMUB | In distribution | |
| S141–SBMU | In distribution | |
| S731RS3-SBB | In distribution | |
| S741A-ARMUB | In distribution | |
| S331-1ARMUB | In distribution | |
| S14151ARMU | In distribution | |
| S331–ARMU | In distribution | |
| S13152ARMUB | In distribution | |
| S546–SWMUB | In distribution | |
| S14152SBMUB | In distribution | |
| S131–SBMU | In distribution | |
| S13151ARMU | In distribution | |
| S341–ARMU | In distribution | |
| S746-1SBMUB | In distribution | |
| S730-2ARMUB | In distribution | |
| S741RS4-ARB | In distribution | |
| S740-2ARMUB | In distribution | |
| S731-1ARMUB | In distribution | |
| S141–ARMU | In distribution | |
| S542-1YLMUB | In distribution | |
| S14152SBMU | In distribution | |
| S731RS3-ARB | In distribution | |
| S546-2SWMUB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Dalton Scooter | Dalton Technology, Inc. | 12 |
Showing 12 of 149. All products under Vehicle, Motorized 3-Wheeled
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142912 | 2015-06-23 |
| K142162 | 2015-05-01 |
| K013788 | 2001-12-11 |
| K011751 | 2001-08-06 |
| K011753 | 2001-08-03 |
| K003815 | 2000-12-27 |
| K952042 | 1996-03-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Merits Health Products, Inc. | 510(k) number | 2021-04-01 | Class II | Process change control | Seat baseplate pin has broken in the field. | 189 units |
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.