SGB

Pain Assessment Software In Non-Communicative Adults

Product code

SGB

Device name

Pain Assessment Software In Non-Communicative Adults

Device class

Class 2

21 CFR

21 CFR 882.1472

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification 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.

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: 2025-10-06.