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ASSURE Wearable Cardioverter Defibrillator (WCD) System

FDA PMA

Class III (US FDA PMA)

PMA P200037

by Kestra Medical Technologies, Inc.

Identity

Trade Name
ASSURE Wearable Cardioverter Defibrillator (WCD) System FDA PMA
Generic Name
Wearable automated external defibrillator FDA PMA

Identifiers

PMA Number
P200037 FDA PMA
FDA Product Code
MVK FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The ASSURE Wearable Cardioverter Defibrillator (WCD) System 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 is designed to continuously monitor heart rhythm and deliver a therapeutic shock if a life-threatening arrhythmia is detected.

The system is supplied as a wearable device for use in ambulatory or home settings. It is non-sterile, reusable, and not evaluated for MRI safety. Authorization is based on FDA PMA approval (P200037) under product code MVK, with no claims made regarding sterility, single-use status, or MRI compatibility in the provided data.

Frequently asked questions

What is the ASSURE Wearable Cardioverter Defibrillator (WCD) System intended for?

The ASSURE WCD System is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator, based on the FDA PMA approval documentation.

Is the ASSURE WCD System sterile or single-use?

The provided device data does not specify that the ASSURE WCD System is sterile or single-use; it is described as a wearable automated external defibrillator intended for repeated patient use in ambulatory settings.

What regulatory authorization does the ASSURE WCD System have?

The ASSURE WCD System has received FDA Premarket Approval (PMA) under application number P200037, as stated in the AUTHORIZATIONS and PMA_NUMBER fields of the device data.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Kestra Medical Technologies, Inc.

Sources (1)

  • FDA PMA P200037 24 fields · synced Sep 18, 2026