FDA product code SBO

Bed-Patient Activity Monitoring System

General Hospital·Class 1·21 CFR 880.2400
US regulatory classifications
US Product Code (FDA)
SBO
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 880.2400
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Bed-Patient Activity Monitoring System is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.