Devices · Avive Solutions, Inc.

Avive Automated External Defibrillator (AED) System

Avive Solutions, Inc. is listed for Avive Automated External Defibrillator (AED) System (P210015). The FDA list gives October 31, 2022 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the PMA pathway. openFDA describes product code MKJ as “Automated External Defibrillators (Non-Wearable)”: This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only. openFDA records decision code APPR for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210015

Official FDA database record

Date of final decision

October 31, 2022

Company on the FDA list

Avive Solutions, Inc.

Lead panel

Cardiovascular

Primary product code

MKJ

openFDA device name for the code

Automated External Defibrillators (Non-Wearable)

Device class

3

Regulation number

870.5310

openFDA decision description

Not returned

openFDA decision code

APPR

Statement or summary label

Statement