Over-The-Counter Automated External Defibrillator
- US Product Code (FDA)
- NSAView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 870.5310View CFR Regulation →
- Medical specialty
- Cardiovascular
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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.
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Over-The-Counter Automated External Defibrillator is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.