Data / Medical devices / China / Zhejiang Zhonglei Medical Technology Co.ltd.
Zhejiang Zhonglei Medical Technology Co.ltd.: FDA-registered device maker in Lishui City Zhejiang, China, 3 510(k) clearances
Zhejiang Zhonglei Medical Technology Co.ltd. is registered with the FDA (registration 3032587493) in Lishui City Zhejiang, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3032587493
- Address
- 1st floor, 2nd floor, No. 66, Dayuan Street, Nanmingshan Street, Liandu District, Lishui City Zhejiang, China, 323000
- Owner or operator
- Zhejiang Zhonglei Medical Technology Co.Ltd. (10091327)
- Roles
- Manufacturer
- First device listed
- August 27, 2024
- Registered through
- 2026
- Brand names listed
- Power wheelchair (N6101), Power wheelchair (N6102), Power wheelchair (N6103)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 27, 2024 | K242308 | Power wheelchair | ITI | Substantially Equivalent | Zhejiang Zhonglei Medical Technology Co. , Ltd. | accessdata.fda.gov |
| November 18, 2024 | K242402 | Power wheelchair | ITI | Substantially Equivalent | Zhejiang Zhonglei Medical Technology Co. , Ltd. | accessdata.fda.gov |
| August 13, 2024 | K241686 | Power wheelchair (N6101) | ITI | Substantially Equivalent | Zhejiang Zhonglei Medical Technology Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 27, 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.