PMK

Cpr Aid Device Without Feedback

Product code

PMK

Device name

Cpr Aid Device Without Feedback

Device class

Class 1

21 CFR

21 CFR 870.5210

Medical specialty

Cardiovascular

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.

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