# K083148: Telectrode Wet Gel Ecg Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Nov 7, 2008 after 14 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: 1 generation back to K982521 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes, Leonhard Lang Co. (1999) Summary page 1.

## Indications for use
TELECTRODE Wet gel ECG Electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring. The intended patient population can be adult and pediatric, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).

Source page: https://510kreport.com/device/K083148
Methodology: https://510kreport.com/methodology