meddevicedb.com FDA Device Reference

PainChek (PainChek Adult)

DEN240073 Class II Direct
Decision Date
2025-10-06
Sponsor / Applicant
Painchek Limited (Ltd.)

Technical Specification

510(k) Submission ID DEN240073
Product Code SGB
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1472
Decision Date 2025-10-06
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PainChek (PainChek Adult) received FDA 510(k) clearance under submission number DEN240073, sponsored by Painchek Limited (Ltd.). The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-10-06.

Classification & Regulation

This clearance is catalogued under FDA product code SGB and 21 CFR 882.1472, within the Neurology review panel as a Class II device.