NSA

Over-The-Counter Automated External Defibrillator

Product code

NSA

Device name

Over-The-Counter Automated External Defibrillator

Device class

Class 3

21 CFR

21 CFR 870.5310

Medical specialty

Cardiovascular

Marketing pathway

PMA

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).