SBO

Bed-Patient Activity Monitoring System

Product code

SBO

Device name

Bed-Patient Activity Monitoring System

Device class

Class 1

21 CFR

21 CFR 880.2400

Medical specialty

General Hospital

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-06-21.

1 summaries are archived here for direct download.