OVR

Kit, First Aid, Talking

Product code

OVR

Device name

Kit, First Aid, Talking

Device class

Class 1

21 CFR

21 CFR 878.4014

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

FDA classification definition

The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.

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