Data / Medical devices / China / Zhejiang Nysin Medical Co., Ltd.
Zhejiang Nysin Medical Co., Ltd.: FDA-registered device maker in Jinhua Zhejiang, China, 5 510(k) clearances
Zhejiang Nysin Medical Co., Ltd. is registered with the FDA (registration 3033860076) in Jinhua Zhejiang, China. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033860076
- Address
- Building 13, No. 305 Jiulong North Road, Dongcheng District, Yongkang, Jinhua Zhejiang, China, 321300
- Owner or operator
- Zhejiang Nysin Medical Co., Ltd. (10091801)
- Roles
- Manufacturer
- First device listed
- November 3, 2024
- Registered through
- 2026
- Brand names listed
- Electric Scooter (DDF100), Powered Wheelchair, Powered Wheelchair (NXN20-208, NXN20-211), Powered Wheelchair (NXN20-209), ROLLATOR, Wheelchair, Powered, XFGW25-203, XFGW30-107
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2026 | K252275 | Electric Scooter (DDF100) | INI | Substantially Equivalent | Zhejiang Nysin Medical Co., Ltd. | accessdata.fda.gov |
| November 22, 2024 | K241529 | Powered Wheelchair (NXN20-209) | ITI | Substantially Equivalent | Zhejiang Nysin Medical Co., Ltd. | accessdata.fda.gov |
| November 20, 2024 | K241603 | Powered Wheelchair (NXN20-208, NXN20-211) | ITI | Substantially Equivalent | Zhejiang Nysin Medical Co., Ltd. | accessdata.fda.gov |
| September 16, 2024 | K241379 | Powered Wheelchair (NXN20-205, NXN20-205M) | ITI | Substantially Equivalent | Zhejiang Nysin Medical Co., Ltd. | accessdata.fda.gov |
| January 10, 2022 | K212854 | Powered Wheelchair | ITI | Substantially Equivalent | Zhejiang Qianxi Vehicle Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Wheelchair, Powered
- All makers of Walker, Mechanical
Updated January 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.