Data / Medical devices / China / Zhejiang Hfizer Medical Equipment Co.,ltd
Zhejiang Hfizer Medical Equipment Co.,ltd: FDA-registered device maker in Yongkang City Zhejiang, China, 2 510(k) clearances
Zhejiang Hfizer Medical Equipment Co.,ltd is registered with the FDA (registration 3031595780) in Yongkang City Zhejiang, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031595780
- Address
- Yunliu Road, Baiyun Industrial Functional Zone, Jiangnan Street, Yongkang City Zhejiang, China, 321300
- Owner or operator
- Zhejiang Hfizer Medical Equipment CO.,LTD (10091056)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 23, 2024
- Registered through
- 2026
- Brand names listed
- Electric wheelchair, Electric wheelchair (C001), Lift chair, Walker, Wheelchair, Rollator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Positioning, Electric | INO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| September 12, 2024 | K242136 | Electric wheelchair (C001) | ITI | Substantially Equivalent | Zhejiang Hfizer Medical Equipment Co., Ltd. | accessdata.fda.gov |
| June 20, 2024 | K240673 | Electric wheelchair | ITI | Substantially Equivalent | Zhejiang Hfizer Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Positioning, Electric
- All makers of Wheelchair, Powered
- All makers of Walker, Mechanical
Updated September 12, 2024. 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.