# K031174: Body Signal Ecg Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Wandy Rubber Industrial Co., Ltd.
- Decided: Jul 10, 2003 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Body Signal ECG Electrodes are designed for use in general electrocardiograph1 procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.

Source page: https://510kreport.com/device/K031174
Methodology: https://510kreport.com/methodology