Jiangsu Intco Medical Products Co., Ltd.
Registered establishment in Zhenjiang New District, Jiangsu, China. 18 device types, 3 clearances.
Jiangsu Intco Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Crutch, Bag, Ice and 16 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3005260401 |
| FEI number | 3005260401 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 江苏英科医疗制品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Zhenjiang New District |
|---|---|
| Province | Jiangsu |
| Address | No.298, Yandunshan Road |
| Postal code | 212132 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adhesive Backed Thermal Skin Patches | Class 1 | heat patch | 2018 | 48 |
| Armrest, Wheelchair | Class 1 | wheelchair accessories | 2017 | 29 |
| Bag, Ice | Class 1 | ICE BAG | 2022 | 86 |
| Bed, Manual | Class 1 | Bed, General Hospital Use | 2023 | 122 |
| Chair And Table, Medical | Class 1 | transport chairs | 2014 | 94 |
| Chair, Geriatric | Class 1 | Chair, Geriatric | 2023 | 11 |
| Chair, With Casters | Class 1 | Hospital Table | 2021 | 85 |
| Crutch | Class 1 | Crutches, Intco | 2022 | 112 |
| Footrest, Wheelchair | Class 1 | Footrest, legrest | 2022 | 25 |
| Infant Heel Warmer (Chemical Heat Pack) | Class 1 | Infant Heel Warmer | 2012 | 2 |
| Lift, Patient, Non-Ac-Powered | Class 1 | Lift, Patient, Non-Ac-Powered | 2019 | 71 |
| Pack, Hot Or Cold, Disposable | Class 1 | Pack, HOT OR Cold, Disposable, hot or cold pack, disposable | 2012 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Pack, hot or cold, reusable, Cold Pack, Disposable | 2012 | 178 |
| Table, Mechanical | Class 1 | Over Bed Table | 2010 | 46 |
| Tips And Pads, Cane, Crutch And Walker | Class 1 | Tips AND Pads, Cane, Crutch AND Walker | 2008 | 69 |
| Walker, Mechanical | Class 1 | Walker, Mechanical | 2008 | 183 |
| Wheelchair, Mechanical | Class 1 | Wheelchair, Wheelchair, mechanical | 2007 | 46 |
| Wheelchair, Powered | Class 2 | Wheelchair, Powered | 2021 | 62 |
Clearances
3 clearances name Jiangsu Intco Medical Products Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253257 | 2026-06-08 | INI | Traditional | This company |
| K253241 | 2026-05-13 | ITI | Traditional | This company |
| K202482 | 2021-03-18 | ITI | Traditional | This company |
| K162621 | 2017-04-17 | IOR | Traditional | Invacare GmbH |
| K103212 | 2011-01-03 | IOR | Traditional | Whirlwind Wheelchair International |
| K053254 | 2006-09-19 | MPO | Traditional | Shanghai Intco Medical Supply Co., Ltd. |
| K052468 | 2005-10-05 | IOR | Traditional | Intco Metal Products (Zhenjiang) Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 1,200+ |
| Main products | Disposable gloves, Medical protective equipment, Wheelchairs, Walkers |
| Certifications | ISO13485 |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
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.