# K061977: Pelex-04 Wireless Electrocardiograph with Software Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Pinmed, Inc.
- Decided: Jul 21, 2006 after 8 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb (2010), 1 descendant of its own
- K142352: CardiacLinx (2015), 0 descendants of its own

## Indications for use
1-12 lead electrocardiograph capable of recording and transmitting standard FCGs for the purpose of cardiac monitoring and diagnosis; the system incorporates recordingz/ transmitting circLitry, a package of firmware and software, and is intended for use h\ a medical protlessional * The ECG can be recorded and transmitted to a local or remote receiving station for consultation wxith a medical professional * T'Ile [CG can be recorded and transmitted to a local or remote hand-held de\ ice or a Personal Computer or a printer for viewing and processing . \llows patients at Jelotc locations to display and transmit their lICG data to medical prIoIessioll• viaa~tcomImlnictlI o device to a i'reote server Iitcirled for self-testing I\ patients and 1y healthcare professionals at home and in medical seilings

Source page: https://510kreport.com/device/K061977
Methodology: https://510kreport.com/methodology