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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed-Patient Activity Monitoring System
510(k) Number K233096
Device Name PRESSUREALERT® Pressure Monitoring System
Applicant
Position Health, LLC
736 N. Western Ave., Suite 314
Lake Forest,  IL  60045
Applicant Contact Kristi Leigh
Correspondent
Position Health, LLC
736 N. Western Ave., Suite 314
Lake Forest,  ID  60045
Correspondent Contact Kristi Leigh
Regulation Number880.2400
Classification Product Code
SBO  
Date Received09/26/2023
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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