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Recom Battery-Operated Ambulatory Digital Wireless ECG Monitor, Model 100

by Recom Managed Systems, Inc.

510(k) K032882

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK032882 Date28 Jan 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MWJ
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Recom Model 100 is a battery-operated ambulatory ECG monitor system that records up to 48 hours of ECG data for cardiac monitoring and diagnosis by medical professionals when ambulatory monitoring is prescribed by a physician. It is a true 12-lead ambulatory ECG monitor system.

This device is supplied as a complete system for ambulatory cardiac monitoring. It is regulated under FDA 510(k) clearance with product code MWJ and regulation number 870.2800, classified as an Electrocardiograph, Ambulatory (without Analysis). The device is intended for use where Holter monitoring is prescribed by a physician.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Recom Model 100 ECG monitor used for?

    The Recom Model 100 is a battery-operated ambulatory ECG monitor system that records up to 48 hours of ECG data for cardiac monitoring and diagnosis by medical professionals when ambulatory monitoring is prescribed by a physician.

  • How is the Recom Model 100 ECG monitor supplied?

    The device is supplied as a complete system for ambulatory cardiac monitoring, including all necessary components for recording and transmitting ECG data.

  • Is the Recom Model 100 ECG monitor reusable or single-use?

    The device is designed for repeated use in clinical settings, as it is a complete system for ambulatory cardiac monitoring that can be used for multiple patients with appropriate cleaning and disinfection between uses.

  • What regulatory approvals does the Recom Model 100 ECG monitor have?

    The Recom Model 100 is regulated under FDA 510(k) clearance with product code MWJ and regulation number 870.2800, classified as an Electrocardiograph, Ambulatory (without Analysis).