Data / Medical devices / China / Shanghai Intco Electrode Manufacturing Co Ltd
Shanghai Intco Electrode Manufacturing Co Ltd: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
Shanghai Intco Electrode Manufacturing Co Ltd is registered with the FDA (registration 3004537821) in Shanghai, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 10, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004537821
- Address
- No. 1358, Hubin Road Fengxian District, Shanghai, China, 201417
- Owner or operator
- Shanghai Intco Electrode Manufacturing Co Ltd (10044050)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 23, 2013
- Registered through
- 2026
- Brand names listed
- ECG Electrode, Electrode, Electrocardiograph, Electrode, electrocardiograph, Monitoring Electrodes, Prewired Neonatal ECG Electrodes, TAB Electrode, TENS Electrode, eletrode
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 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 |
|---|---|---|---|---|---|---|
| May 10, 2010 | K093327 | INTCO TAB ELECTRODE | DRX | Substantially Equivalent | Shanghai Intco Electrode Manufacturing Co., Ltd. | accessdata.fda.gov |
| September 15, 2004 | K041954 | DISPOSABLE MONITORING ELECTRODES | DRX | Substantially Equivalent | Shanghai Intco Electrode Manufacturing Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 10, 2010. 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.