Name: Predicase
Price: 199 USD

K-number	DEN240073
Device name	PainChek (PainChek Adult)
Applicant	Painchek Limited (Ltd.)
Product code	SGB
Device class	Class II
Decision date	Oct 6, 2025
Decision	Not Substantially Equivalent
Regulation	882.1472

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PainChek (PainChek Adult)

Everything you need for a 510(k) submission. Nothing you don't.