510(k) K233096
K233096 is an FDA 510(k) premarket notification submitted by Position Health, LLC for the device "PRESSUREALERT® Pressure Monitoring System". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code SBO (Bed-Patient Activity Monitoring System), a Class I device regulated under 21 CFR 880.2400.
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.