Data / Medical devices / China / Nanjing Kangni Smart Technology Co.,ltd.
Nanjing Kangni Smart Technology Co.,ltd.: FDA-registered device maker in Nanjing Jiangsu, China, 2 510(k) clearances
Nanjing Kangni Smart Technology Co.,ltd. is registered with the FDA (registration 3039857114) in Nanjing Jiangsu, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 5, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3039857114
- Address
- No.11 Hengjing Rd. Economic & Technological Development Zone, Nanjing Jiangsu, China, 21146
- Owner or operator
- Nanjing Kangni Smart Technology Co.,Ltd. (10094531)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 5, 2025
- Registered through
- 2027
- Brand names listed
- Electrically powered wheelchair, Folding Mobility Scooter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | 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 |
|---|---|---|---|---|---|---|
| December 5, 2025 | K252494 | Electrically powered wheelchair (KZ301B) | ITI | Substantially Equivalent | Nanjing Kangni Smart Technology Co., Ltd. | accessdata.fda.gov |
| October 6, 2025 | K252502 | Folding Mobility Scooter (KD101) | INI | Substantially Equivalent | Nanjing Kangni Smart Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 5, 2025. 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.