# Bed-Patient Activity Monitoring System
> **Product code: SBO** · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.2400
## Classification
- **FDA Product Code:** SBO
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 880.2400
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SBO)
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