# K093327: Intco Tab Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Shanghai Intco Electrode Manufacturing Co., Ltd.
- Decided: May 10, 2010 after 196 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960968 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030509: Skintact Ecg Tab Electrode, Leonhard Lang GmbH (2003) Summary page 1.

## Indications for use
INTCO Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include patient ECG surveillance and ECG diagnosis recording. INTCO Tab Electrodes are non-sterile and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K093327
Methodology: https://510kreport.com/methodology