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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed-patient activity monitoring system
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.
Product CodeSBO
Regulation Number 880.2400
Device Class 1


Premarket Reviews
ManufacturerDecision
WALGREEN HEALTH SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

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