SGB

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Pain Assessment Software In Non-Communicative Adults

Device class

Class II (moderate risk)

Regulation

21 CFR 882.1472

Medical specialty

Neurology

FDA 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.

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