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LifeVest Wearable Defibrillator

FDA PMAFDA UDIEUDAMED

Class III (US FDA PMA)

PMA P010030Ref 10A0985

by ZOLL Manufacturing Corporation

Identity

Trade Name
LifeVest Wearable Defibrillator, Model 4000 EUDAMED
WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST FDA PMA
LifeVest Wearable Defibrillator FDA UDI
Generic Name
Wearable automated external defibrillator FDA PMA
Wearable defibrillation system FDA UDI
Device Name
LifeVest Wearable Defibrillator - Battery Charger EUDAMED
Model / Reference
10A0985 EUDAMED
LifeVest 4000 Battery Charger FDA UDI

Identifiers

Catalog Number
10A0985 FDA UDI
Primary DI / UDI-DI
00855778005029 EUDAMEDFDA UDI
Basic UDI-DI
0855778005P010030BC75 EUDAMED
Direct Marketing DI
00855778005029 EUDAMED
PMA Number
P010030 FDA PMAFDA UDI
FDA Product Code
MVK FDA PMAFDA UDI
EMDN Code
C020480 CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES EUDAMED
GMDN Term
Wearable defibrillation system FDA UDI

Classification

Device Class
Class I EUDAMED
Class III FDA PMAFDA UDI
Market of Registration
France EUDAMED
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The LifeVest Wearable Defibrillator is a wearable automated external defibrillator indicated for adult patients at risk for sudden cardiac arrest who are not candidates for or refuse an implantable defibrillator. It provides continuous monitoring and automated treatment of life-threatening arrhythmias.

Supplied as a wearable vest system, the device is designed for outpatient use and is non-sterile. It is reusable with replaceable components and has received FDA PMA approval (P010030) and MDR authorization. The system includes electrodes, monitor, and alarm components worn under clothing.

Frequently asked questions

Who is the LifeVest Wearable Defibrillator intended for?

The LifeVest Wearable Defibrillator is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator, as stated in the approval documentation for the WCD 2000 system.

Is the LifeVest Wearable Defibrillator sterile or single-use?

The LifeVest Wearable Defibrillator is supplied as a non-sterile, reusable system with replaceable components such as electrodes and batteries, designed for repeated patient use under clinical supervision.

What regulatory authorizations does the LifeVest Wearable Defibrillator have?

The LifeVest Wearable Defibrillator has received FDA PMA approval (application number P010030) and MDR authorization, confirming its regulatory status for marketing and use in the specified patient population.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Die LifeVest Defibrillatorweste – Übersicht für Patienten | ZOLL, Die LifeVest Defibrillatorweste | ZOLL, LifeVest (Defibrillatorweste) - OPED Wundversorgung, TRAGBAREDEFIBRILLATOR-WESTE (WCD, LifeVest) – ARVC …

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_PMA

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Manufacturer

Manufacturer
ZOLL Manufacturing Corporation

Sources (3)

  • FDA PMA P010030 24 fields · synced Sep 18, 2026
  • FDA UDI a2769b96-e44a-4691-ba81-1d265c953d68 34 fields · synced May 27, 2026
  • EUDAMED 505c08cc-8bc1-4bef-bb95-dd8d8f3fdcca 61 fields · synced Jun 19, 2026