Nanjing Kangni Smart Technology Co., Ltd.
Manufacturer and brand owner in Nanjing, Jiangsu, China. 2 device types, 2 products catalogued, 2 clearances.
Nanjing Kangni Smart Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Wheelchair, Powered, Vehicle, Motorized 3-Wheeled. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
2device types registered with the FDA
2products catalogued under its own name
2510(k) clearances
Registration
| Registered name | NANJING KANGNI SMART TECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3039857114 |
| FEI number | 3039857114 |
| DUNS | 544542471 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 南京康尼智能技术有限公司 |
|---|---|
| Unified social credit code | 91320106MA1MRX8D3J |
| Source | NMPA UDI database |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | No.11 Hengjing Rd. Economic & Technological Development Zone |
| Postal code | 21146 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | Class 2 | Folding Mobility Scooter | 2025 | 41 |
| Wheelchair, Powered | Class 2 | Electrically powered wheelchair | 2025 | 62 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Nanjing Kangni Smart Technology Co., Ltd. | INI | 1 |
| Nanjing Kangni Smart Technology Co., Ltd. | ITI | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252494 | 2025-12-05 | ITI | Traditional | This company |
| K252502 | 2025-10-06 | INI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Factory area | 8000 |
| Main products | intelligent wheelchairs, electric transfer vehicles, endoscopy surgical beds, electric transfer machines, medical equipment |
| Certifications | ISO13485, Class II medical device license, CNAS certification |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.