Heartway Medical Products Co., Ltd.
16 catalogue numbers from S17, listed by Heartway Medical Products Co., Ltd., Taiwan, under Vehicle, Motorized 3-Wheeled. 41 manufacturers in China are registered for this product code.
41manufacturers in China registered for this device type
16catalogue numbers in this listing
15510(k) clearances naming this product code
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 | Heartway Medical Products Co., Ltd., Taiwan |
|---|---|
| FDA product code | INI |
| Device type | Vehicle, Motorized 3-Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3800 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K151656 |
| Record published | 2017-01-23 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S17 | In distribution | |
| P33 | In distribution | |
| S9 | In distribution | |
| PF2 | In distribution | |
| S33 | In distribution | |
| S19 | In distribution | |
| S12 | In distribution | |
| S34 | In distribution | |
| PT7 | In distribution | |
| S15 | In distribution | |
| S16 | In distribution | |
| S11 | In distribution | |
| PF3 | In distribution | |
| PF6 | In distribution | |
| PF7 | In distribution | |
| S8 | 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 |
| 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 |
|---|---|
| K220227 | 2022-10-12 |
| K151656 | 2015-11-25 |
| K150998 | 2015-09-29 |
| K150987 | 2015-09-22 |
| K132855 | 2014-08-29 |
| K101142 | 2010-05-26 |
| K101143 | 2010-05-26 |
| K092650 | 2009-10-09 |
| K092155 | 2009-09-21 |
| K092154 | 2009-09-21 |
| K080242 | 2008-02-27 |
| K073044 | 2007-12-07 |
| K072104 | 2007-08-17 |
| K071007 | 2007-04-19 |
| K070493 | 2007-03-23 |
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.