# Over-The-Counter Automated External Defibrillator
> **Product code: NSA** · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.5310
## Classification
- **FDA Product Code:** NSA
- **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:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

Automated external defibrillators are devices that 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 over-the-counter without a prescription.  The device is to be used on adults and children who are either > 8 years old or > 55 lbs.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NSA)
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