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Bed-Patient Activity Monitoring System

FDA product code SBO · 1 cleared devices

Class 1 General Hospital
Regulation
21 CFR 880.2400
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-06-21 – 2024-06-21

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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