510(k) K233096

PRESSUREALERT® Pressure Monitoring System by Position Health, LLC — Product Code SBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 21, 2024
Date Received: September 26, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bed-Patient Activity Monitoring System
Device Class: Class I
Regulation Number: 880.2400
Review Panel: HO
Submission Type

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.