# Automated External Defibrillators (Non-Wearable)
> **Product code: MKJ** · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.5310
## Classification
- **FDA Product Code:** MKJ
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 870.5310
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 228
- **Registered establishments:** 64
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=MKJ)
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