1 device · 1 company · 2022
Product code MKJ: Automated External Defibrillators (Non-Wearable)
1 device under product code MKJ, 2022, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Automated External Defibrillators (Non-Wearable). 21 CFR 870.5310, Class III. 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. MAUDE held 270,712 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Avive Automated External DefibrillatorP210015 · PMA | Avive Solutions, Inc. | Cardiovascular | database entry |
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