K-number	DEN240076
Device name	Modius Lean
Applicant	Neurovalens Limited
Product code	SFW
Device class	Class I
Decision date	Oct 17, 2025
Decision	Not Substantially Equivalent
Regulation	876.5984

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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Modius Lean

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