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Avive Automated External Defibrillator (AED) System

FDA PMA

Class III (US FDA PMA)

PMA P210015

by Avive Solutions, Inc.

Identity

Trade Name
Avive Automated External Defibrillator (AED) System FDA PMA
Generic Name
Automated external defibrillators (non-wearable) FDA PMA

Identifiers

PMA Number
P210015 FDA PMA
FDA Product Code
MKJ FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 870.5310 FDA PMA
Regulation Number
870.5310 FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Avive Automated External Defibrillator (AED) System is a non-wearable automated external defibrillator designed for emergency treatment of life-threatening cardiac arrhythmias. It delivers therapeutic shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest.

Supplied as a complete system for use in public and clinical settings, the device is intended for use by trained responders. It is regulated under FDA PMA approval (P210015) and classified as a Class III medical device under regulation number 870.5310. The system includes all necessary components for operation and is not designated as single-use or reusable in the provided data.

Frequently asked questions

What type of device is the Avive Automated External Defibrillator (AED) System?

The Avive Automated External Defibrillator (AED) System is classified as a non-wearable automated external defibrillator, which is a medical device designed to analyze heart rhythms and deliver an electric shock to help restore normal rhythm during sudden cardiac arrest.

Who manufactures the Avive AED System and what regulatory pathway was used for its approval?

The Avive AED System is manufactured by Avive Solutions, Inc., and received approval through the FDA Premarket Approval (PMA) pathway, as indicated by the PMA number P210015 and the AUTHORIZATIONS field listing FDA_PMA.

Is the Avive AED System intended for wearable use?

No, the Avive AED System is explicitly defined as a non-wearable automated external defibrillator in the generic_name and openfda fields, which specify 'Automated External Defibrillators (Non-Wearable)'.

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
Avive Solutions, Inc.

Sources (1)

  • FDA PMA P210015 24 fields · synced Sep 18, 2026