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ZOLL Manufacturing Corporation

United States·US-MF-000027987

Last updated September 17, 2026

About

From the team behind the LifeVest wearable defibrillator, ZOLL offers a range of technologies designed to help acute cardiac patients get back to living their lives.

From the manufacturer's own website. Source

Information

Country: United States
Address: 121, Gamma Drive, Pittsburgh, United States
Website: lifevest.zoll.com
LinkedIn: linkedin.com/company/zoll-cardiac-management-solutions
Facebook: facebook.com/profile.php
Email: [email protected]
Phone: 800.543.3267
PRRC Contact: Darryl Griffith
EUDAMED SRN: US-MF-000027987
FDA FEI Number: 3008642652
DUNS Number: —

Catalogue (35)

Device	Model / Reference	Registries	Class	Status
LifeVest Wearable Defibrillator, Model 4000	11A1004	EUDAMED	Class I	Active
LifeVest Wearable Defibrillator	LifeVest 4000 Monitor	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 4000 Electrode Belt	EUDAMEDFDA UDI	Class III	Active
Hospital Wearable Defibrillator	HWD 1000 Therapy Electrode	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 5100 Monitor	FDA UDI	Class III	Active
Hospital Wearable Defibrillator	HWD 1000 Monitor	FDA UDI	Class III	Active
Hospital Wearable Defibrillator	HWD 1000 Electrode Cable	FDA UDI	Class III	Active
ZOLL ECG Analysis Software	Version 1.0	FDA UDI	Class II	Active
ZOLL Cardiac Monitor	ZOLL Cardiac Monitor	FDA UDI	Class II	Active
Hospital Wearable Defibrillator	HWD 1000 Battery Pack	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest Garment B (2.3)	EUDAMEDFDA UDI	Class III	Active
ZOLL Charger	Charger	FDA UDI	Class II	Active
LifeVest Wearable Defibrillator	LifeVest Garment A	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 3000 Modem	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 4000 Battery Pack	EUDAMEDFDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 3000 Battery Pack	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 4000 Battery Charger	EUDAMEDFDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 5100 Battery Charger	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest Garment B	FDA UDI	Class III	Active
uCor Heart Failure and Arrhythmia Management System	Gateway	FDA UDI	Class II	Active
LifeVest Wearable Defibrillator	LifeVest 5100 Battery Pack	FDA UDI	Class III	Active
LifeVest Wearable Defibrillator	LifeVest 4000 Electrode Belt	EUDAMEDFDA UDI	Class III	Active
ZOLL Arrhythmia Management System	Sensor	FDA UDI	Class II	Active
LifeVest Wearable Defibrillator	LifeVest 5100 Electrode Belt	FDA UDI	Class III	Active
Hospital Wearable Defibrillator	HWD 1000 Battery Charger	FDA UDI	Class III	Active
uCor Heart Failure and Arrhythmia Management System	Gateway (4G)	FDA UDI	Class II	Active
LifeVest Wearable Defibrillator	LifeVest Garment B (2.4)	EUDAMEDFDA UDI	Class III	Active
uCor Heart Failure and Arrhythmia Management System	Sensor	FDA UDI	Class II	Active
ZOLL Patch	Patch	FDA UDI	Class II	Active
ZOLL Arrhythmia Management System	Gateway	FDA UDI	Class II	Active
ZOLL Arrhythmia Management System	Gateway (4G)	FDA UDI	Class II	Active
ZOLL ECG Analysis Software	K182093	FDA 510(k)	Class II	Active
ZOLL Arrhythmia Management Sysyem	K190939	FDA 510(k)	Class II	Active
µCor Heart Failure and Arrhythmia Management System	K172510	FDA 510(k)	Class II	Active
Lifevest Wearable Defibrillator	P010030	EUDAMEDFDA PMAFDA UDI	Class III	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 12, 2017	Z-0353-2018	—	terminated	Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure