DeviceClearance

Product code QTV— General Hospital

Soteria Bed Barrier

Classification name
Mattress And Bed Deck Cover (Medical Purposes)
Device class
Class 1
Regulation
21 CFR 880.6190
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame.”

— U.S. Food and Drug Administration, device classification record for product code QTV under 21 CFR 880.6190, via openFDA

Market context for product code QTV

FDA has cleared 1 device under product code QTV, all in 2022, 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 QTV

Recent clearances under product code QTV

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