# K061293: Telaheart Digital Recorder

- Pathway: 510(k) (Abbreviated)
- Applicant: North East Monitoring, Inc.
- Decided: Aug 25, 2006 after 108 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K923930 (1992). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041901: SD360 Digital Recorder/SD360 Holter Digital Recorder, North East Monitoring, Inc. (2004) Summary page 2.
- K030856: ER800 Series Ecg Event Recorder, Braemar Corp. (2003) Summary page 2.

## Most influential descendants
- K142424: DR300 Holter Monitor (2014), 3 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own
- K070014: Auto Detect for Telaheart DR200/E-a (2007), 0 descendants of its own

## Indications for use
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode. Hotter Mode Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation. Event Recorder The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.

Source page: https://510kreport.com/device/K061293
Methodology: https://510kreport.com/methodology