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.