Product Code: NSA FDA class 3 21 CFR 870.5310

Over-The-Counter Automated External Defibrillator

Cardiovascular

The Over-The-Counter Automated External Defibrillator (AED) is a consumer-accessible device that uses external pad-type electrodes to detect and treat ventricular fibrillation in suspected victims of sudden cardiac arrest by delivering an electrical shock. It is approved for use without a prescription on adults and children over 8 years old or over 55 pounds who are unresponsive and not breathing normally. As an FDA Class 3 device regulated under 21 CFR 870.5310, it requires Premarket Approval (PMA) given its life-sustaining and high-risk nature. The product code is NSA, falling within the Cardiovascular specialty. This device is flagged as life-sustaining, reflecting its critical role in emergency resuscitation.

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Basic Information

Product Code: NSA
Device Class: FDA class 3
Regulation Number: 870.5310
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 2

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.