DeviceClearance

Product code SGB— Neurology

PainChek (PainChek Adult)

Classification name
Pain Assessment Software In Non-Communicative Adults
Device class
Class 2
Regulation
21 CFR 882.1472
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SGB under 21 CFR 882.1472, via openFDA

Market context for product code SGB

FDA has cleared 1 device under product code SGB, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGB

Recent clearances under product code SGB

Data sourced from openFDA. This site is unofficial and independent of the FDA.