# K032882: Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100

- Pathway: 510(k) (Abbreviated)
- Applicant: Recom Managed Systems, Inc.
- Decided: Jan 28, 2004 after 135 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: 2 generations back to K891104 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003707: Cardionet Ambulatory Ecg Monitor, Model CN1000A, Cardionet (2001) Summary page 1.
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 1.

## Indications for use
The Recom Model 100 battery-operated Ambulatory, Digital Wireless ECG Monitor System is a true 12 lead ambulatory ECG monitor system capable of recording up to 48 hours of ECG data for the purpose of cardiac monitoring and diagnosis by a medical professional where ambulatory (Holter) monitoring is prescribed by a physician. The system includes recording of ECG data from each of the 12 leads, RF transmission of the recorded data to a PDA and storage. The stored ECG data is then transferred from the PDA to another device, the Phillips Medical TraceMaster ECG Analysis System for ECG analysis. The Recom Model 100 battery-operated, Ambulatory, Digital, Wireless ECG Monitor System is not intended to sound any physiological alarms. The Recom Model 100 battery-operated, Ambulatory, Digital Wireless ECG Monitor System is only to be used by or on the order of a physician.

Source page: https://510kreport.com/device/K032882
Methodology: https://510kreport.com/methodology