DeviceClearance

Product code SBO— General Hospital

PRESSUREALERT® Pressure Monitoring System

Classification name
Bed-Patient Activity Monitoring System
Device class
Class 1
Regulation
21 CFR 880.2400
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or other signal when patient activity deviates from assigned pressure prevention parameters.”

— U.S. Food and Drug Administration, device classification record for product code SBO under 21 CFR 880.2400, via openFDA

Market context for product code SBO

FDA has cleared 1 device under product code SBO, all in 2024, 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 SBO

Recent clearances under product code SBO

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