Product Code: MWJ FDA class 2 21 CFR 870.2800

Electrocardiograph, Ambulatory (Without Analysis)

Cardiovascular

An Ambulatory Electrocardiograph Without Analysis is a wearable device that continuously records the patient's electrocardiographic (ECG) signal over an extended period (typically 24-48 hours) for later offline review by a clinician, without onboard automated arrhythmia detection or interpretation. It is FDA Class 2, requiring 510(k) clearance, with product code MWJ under 21 CFR 870.2800 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

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FEI Numbers

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Basic Information

Product Code: MWJ
Device Class: FDA class 2
Regulation Number: 870.2800
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 60 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252839	ZywieZ3 Sensor & Adhesive	Jun 18, 2026	Substantially Equivalent	Zywie, Inc.
K231424	HeartBeam AIMIGo(TM) System	Dec 13, 2024	Substantially Equivalent	Heartbeam, Inc.
K233864	ASSURE Wearable ECG	May 07, 2024	Substantially Equivalent	Kestra Medical Technologies, Inc.
K212317	Eclipse MINI Model 98900	Nov 07, 2022	Substantially Equivalent	Spacelabs Healthcare, Ltd.
K222017	Biotres	Jul 28, 2022	Substantially Equivalent	Biotricity
K210758	Q Patch	Jun 02, 2022	Substantially Equivalent	Medicalgorithmics S.A.
K211709	Biotres	Jan 19, 2022	Substantially Equivalent	Biotricity
K211651	Eclipse PRO	Nov 22, 2021	Substantially Equivalent	Spacelabs Healthcare, Ltd.
K173156	Integrated CardioRespiratory System	Jun 08, 2018	Substantially Equivalent	Sensydia, Inc.
K161062	NR Recorder	Jun 13, 2016	Substantially Equivalent	Norav Medical GmbH
K152626	H3+ Holter Recorder	Feb 26, 2016	Substantially Equivalent	Mortara Instrument, Inc.
K142424	DR300 HOLTER MONITOR	Nov 25, 2014	Substantially Equivalent	North East Monitoring, Inc.
K133014	DMS 300-2W HOLTER ECG RECORDER	May 19, 2014	Substantially Equivalent	Diagnostic Monitoring Software
K130294	BRAEMAR CARDIOKEY HOLTER RECORDER	Oct 16, 2013	Substantially Equivalent	Braemar Manufacturing, LLC
K130785	SEER 1000	Jul 26, 2013	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K122272	CARDIOMEM	Mar 28, 2013	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K112573	EZSLEEP SLEEP QUALITY RECORDER	Mar 22, 2012	Substantially Equivalent	Platinum Team Co., Ltd.
K112601	INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER	Nov 09, 2011	Substantially Equivalent	Intricon Datrix Corporation
K101969	MH1 MICROHOLTER RECORDER	Feb 04, 2011	Substantially Equivalent	Exelys, LLC
K101024	KENZ CARDY302 MAX	Jan 06, 2011	Substantially Equivalent	Suzuken Co., Ltd.
K102723	MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS	Dec 09, 2010	Substantially Equivalent	Memtec Corp.
K100310	BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS	Oct 13, 2010	Substantially Equivalent	BTL Industries, Inc.
K100266	ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603	Apr 29, 2010	Substantially Equivalent	Camntech, Ltd.
K083382	CHROMA, MODEL: RZ153C	Aug 13, 2009	Substantially Equivalent	Scottcare Corporation
K091054	WALK400H	Jul 27, 2009	Substantially Equivalent	Et Medical Devices Spa
K073545	AUDICOR, HEMO AMBULATORY MONITOR	Sep 09, 2008	Substantially Equivalent	Inovise Medical, Inc.
K071085	E3-80 PORTABLE ECG RECORDER & ANALYZER	Oct 03, 2007	Substantially Equivalent	Micro-Star International Co., Ltd.
K071733	DL900 SERIES HOLTER RECORDER	Jul 24, 2007	Substantially Equivalent	Braemar, Inc.
K063042	CARDIOMEM CM 3000-12BT	May 30, 2007	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K070014	AUTO DETECT FOR TELAHEART DR200/E-A	May 25, 2007	Substantially Equivalent	North East Monitoring, Inc.
K071011	MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER	Apr 27, 2007	Substantially Equivalent	Braemar, Inc.
K062959	DMS 300-2, 300-3 AND 300-4	Oct 16, 2006	Substantially Equivalent	Diagnostic Monitoring Software
K061293	TELAHEART DIGITAL RECORDER	Aug 25, 2006	Substantially Equivalent	North East Monitoring, Inc.
K051686	CARDIOMEM CM 3000-12	Jul 14, 2005	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K050731	SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM	May 19, 2005	Substantially Equivalent	Ge Medical Systems Information Technologies
K043010	HOLTER RECORDER H3+	Feb 25, 2005	Substantially Equivalent	Mortara Instrument, Inc.
K042469	BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER	Oct 06, 2004	Substantially Equivalent	Braemar, Inc.
K041901	SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER	Aug 31, 2004	Substantially Equivalent	North East Monitoring, Inc.
K032882	RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100	Jan 28, 2004	Substantially Equivalent	Recom Managed Systems, Inc.
K031074	DIGITAL AMBULATORY ECG (HOLTER) RECORDER	Oct 15, 2003	Substantially Equivalent	Datrix
K032276	CLICK HOLTER	Aug 27, 2003	Substantially Equivalent	Remco Italia S.P.A.
K032466	SPIDERVIEW	Aug 22, 2003	Substantially Equivalent	Ela Medical, Inc.
K030856	ER800 SERIES ECG EVENT RECORDER	Mar 28, 2003	Substantially Equivalent	Braemar Corp.
K021470	SEER LIGHT COMPACT DIGITAL HOLTER RECORDER	Nov 14, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K021373	H12+HOLTER RECORDER	Jun 27, 2002	Substantially Equivalent	Mortara Instrument, Inc.
K011837	LIFECARD CF 7 DAY	Jul 13, 2001	Substantially Equivalent	Reynolds Medical , Ltd.
K003707	CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A	May 16, 2001	Substantially Equivalent	Cardionet
K003520	NEXAN SYSTEM, MODEL NX-300	Dec 13, 2000	Substantially Equivalent	Nexan, Ltd.
K001349	CARDIOVISE ECG INTERPRETATIVE SOFTWARE	Jul 27, 2000	Substantially Equivalent	Inovise Medical, Inc.
K001317	ARIA	Jul 21, 2000	Substantially Equivalent	Del Mar Medical Systems, LLC
K001288	DR180-II	Jul 20, 2000	Substantially Equivalent	North East Monitoring, Inc.
K000609	CARDTEL, MODEL NT-100	May 23, 2000	Substantially Equivalent	Cardiac Telecommunications
K992584	PE 501 PC-ECG MONITOR	Jan 13, 2000	Substantially Equivalent	Nhe Corp.
K993643	NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100	Dec 28, 1999	Substantially Equivalent	Nexan Telemed , Ltd.
K993618	DXP1000 HOLTER RECORDER	Nov 24, 1999	Substantially Equivalent	Braemar Corp.
K993617	DIGITRAKPLUS HOLTER RECORDER	Nov 24, 1999	Substantially Equivalent	Braemar Corp.
K992425	TES-20	Oct 19, 1999	Substantially Equivalent	Tes Electrical Electronic Corp.
K982617	TRACER	Apr 09, 1999	Substantially Equivalent	Heartland Medical Systems, Inc.
K982975	DIGITAL ECG HOLTER RECORDER, MODEL DR512	Nov 10, 1998	Substantially Equivalent	Datrix
K982843	CMS-2000	Nov 10, 1998	Substantially Equivalent	Industrial Technology Research Institute