AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

FDA premarket approval P190013 · Automated external defibrillators (non-wearable)

PMA numberP190013

Approval

Applicant
Aed Battery Exchange, LLC
Received
April 29, 2019
Decision date
February 2, 2021 (APPR)
Supplements
1, latest October 28, 2025
Product code
MKJ – Automated External Defibrillators (Non-Wearable)

Official FDA PMA record

Approval order statement

Approval for the AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE). The AED battery supplies power to an AED as required during self maintenance, automated diagnoses, and defibrillation. The 9146-ABE is indicated for use with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E. The G5-ABE is indicated for use with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C. The 5070-ABE is indicated for use with the Philips HeartStart OnSite/Home, models M5066A, M5067A, M5068A, and the FRx, model 861304. The FR3-ABE is indicated for use with the Philips HeartStart FR3, models 861388 and 861389.