PMK · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.5210
Classification
FDA Product Code
PMK
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 870.5210
Review panel
CV
Medical specialty
Cardiovascular
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.