DeviceClearance

Product code OVR— General, Plastic Surgery

SAFETYMATE TALKING FIRST AID

Classification name
Kit, First Aid, Talking
Device class
Class 1
Regulation
21 CFR 878.4014
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OVR under 21 CFR 878.4014, via openFDA

Market context for product code OVR

FDA has cleared 1 device under product code OVR, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OVR

Recent clearances under product code OVR

Data sourced from openFDA. This site is unofficial and independent of the FDA.