FDA Product Code SBO: Bed-patient Activity Monitoring System
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.
Leading manufacturers include Position Health, LLC.
FDA 510(k) Cleared Bed-patient Activity Monitoring System Devices (Product Code SBO)
About Product Code SBO - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBO since 2024, with 1 receiving FDA clearance (average review time: 269 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBO devices are reviewed by the General Hospital panel. Browse all General Hospital devices →