Data / Medical devices / China / Zhejiang Kairui Medical Device Co., Ltd.
Zhejiang Kairui Medical Device Co., Ltd.: FDA-registered device maker in Ruian City Zhejiang, China, 2 510(k) clearances
Zhejiang Kairui Medical Device Co., Ltd. is registered with the FDA (registration 3032014158) in Ruian City Zhejiang, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032014158
- Address
- No.85, Dengyun Road, Tangxia Town, Ruian City Zhejiang, China, 325204
- Owner or operator
- Zhejiang Kairui Medical Device Co., Ltd. (10092053)
- Roles
- Manufacturer
- First device listed
- November 28, 2024
- Registered through
- 2026
- Brand names listed
- Electric Wheelchair (KR8803), Electric wheelchair (KR-8807), Rollator, Transport Wheelchair, Walking Stick
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, With Casters | INM | 1 | Manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | 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 |
|---|---|---|---|---|---|---|
| November 25, 2024 | K241588 | Electric Wheelchair (KR8803) | ITI | Substantially Equivalent | Zhejiang Kairui Medical Device Co., Ltd. | accessdata.fda.gov |
| November 12, 2024 | K242791 | Electric wheelchair (KR-8807) | ITI | Substantially Equivalent | Zhejiang Kairui Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Crutch
- All makers of Wheelchair, Powered
- All makers of Chair, With Casters
- All makers of Walker, Mechanical
Updated November 25, 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.