PMA
P190013: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
FDA PMA · Automated external defibrillators (non-wearable) · Aed Battery Exchange, LLC
Key facts
| PMA number | P190013 |
|---|---|
| Trade name | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Aed Battery Exchange, LLC |
| Owner/operator | AED Battery Exchange, LLC |
| Product code | MKJ |
| Approval date | Feb 2, 2021 |
| Establishment registration | 3009886119 |
| FEI number | 3009886119 |
At a glance
- 1–9 Supplements
- Oct 28, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: