# K973863: Memorytrace Model 4224 Ambulatory Ecg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Hi-Tronics Designs, Inc.
- Decided: Jan 2, 1998 after 85 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.
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
The MEMORYTRACE™ Model 4224 monitor is a patient-operated device designed to record and transmit a patient’s ECG for the documentation of rhythm and/or rate disturbances. The recorded ECG data can be transmitted over a telephone to a standard ECG receiver. The ECG transmissions are intended as aids in evaluating symptomatic episodes of rate disturbances, post-myocardial infarction follow-ups, anti-arrhythmia therapy, and cases that require ST segment analysis. The intended population is from infants whose weight is greater than 10 kg (22 Ibs) through geriatric patients with no upper limit.

Source page: https://510kreport.com/device/K973863
Methodology: https://510kreport.com/methodology