# K063044: Cardiobelt Electrode Belt

- Pathway: 510(k) (Abbreviated)
- Applicant: Monebo Technologies, Inc.
- Decided: Mar 23, 2007 after 170 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: 3 generations back to K863116 (1986). 9 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043361: Accuheart Electrode Belt, Advanced Bioelectric Corporation (2005) Summary page 1.
- K960968: Medi-Trace 200, Medi-Trace 200-30, Graphic Controls Corp. (1996) Summary page 1.
- K012223: CG-2211 Selfcheck Ecg Transmitter, Card Guard Scientific Survival, Ltd. (2001) Summary page 1.

## Most influential descendants
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own
- K121617: Sensicardiac (2012), 10 descendants of its own
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application (2013), 9 descendants of its own
- K181988: eMurmur ID (2019), 7 descendants of its own

## Indications for use
The CardioBeltTM is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBeltTM is compatible for use with Bluetooth equipped ECG instruments capable of receiving BluetoothTM Serial Port Protocol.

Source page: https://510kreport.com/device/K063044
Methodology: https://510kreport.com/methodology