Jiangsu Suntec Medical Technology Co., Ltd.
Registered establishment in Jiepai Danyang, Jiangsu, China. 14 device types.
Jiangsu Suntec Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Aid, Transfer, Stand, Infusion and 12 other device types. Its earliest product listing with the FDA dates from 2014.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3011475060 |
| FEI number | 3011475060 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江苏顺泰医疗科技股份有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Jiepai Danyang |
|---|---|
| Province | Jiangsu |
| Address | Jiepai Industrial Zone |
| Postal code | 212300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Wheelchair | Class 1 | Wheelchair Accessories | 2014 | 80 |
| Adaptor, Hygiene | Class 1 | Bath Chair | 2022 | 193 |
| Aid, Transfer | Class 1 | Transfer Aid | 2025 | 118 |
| Attachment, Commode, Wheelchair | Class 1 | Commode | 2014 | 70 |
| Belt, Wheelchair | Class 1 | Wheelchair Belt | 2024 | 24 |
| Brake, Extension, Wheelchair | Class 1 | Wheelchair Extension Brake | 2014 | 19 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class 1 | Emergency Cart | 2024 | 34 |
| Chair, With Casters | Class 1 | Caster with Chair | 2014 | 85 |
| Components, Wheelchair | Class 1 | Wheelchair Components | 2014 | 54 |
| Cushion, Wheelchair | Class 1 | Wheelchair Cushion | 2014 | 53 |
| Device, Anti-Tip, Wheelchair | Class 1 | Wheelchair Anti-Tip | 2014 | 22 |
| Stand, Infusion | Class 1 | Infusion Stand | 2024 | 75 |
| Walker, Mechanical | Class 1 | Knee Walker, Walker, Rollator | 2019 | 183 |
| Wheelchair, Mechanical | Class 1 | SUNTEC Mechanical Wheelchair, model ST-WL-1000 | 2016 | 46 |
Clearances
No clearance names Jiangsu Suntec Medical Technology Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K152878 | 2016-02-03 | IOR | Traditional | Danyang Suntec Auto Parts Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Wheelchairs, Transport chairs, Commode chairs, Mobility auxiliary tools |
| Export markets | United States, Germany, Poland, Russia, South Korea, Australia, Taiwan |
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.
The manufacturer named here can complete this record.