K-number	K250376
Device name	ViVY
Applicant	Viatherm Therapeutics, LLC
Product code	IMJ
Device class	Class II
Decision date	Nov 5, 2025
Decision	Substantially Equivalent
Regulation	890.5290

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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ViVY

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