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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pain assessment software in non-communicative adults
Definition Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.
Product CodeSGB
Regulation Number 882.1472
Device Class 2


Premarket Reviews
ManufacturerDecision
PAINCHEK LIMITED (LTD.)
  GRANTED 1

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