K-number	K250687
Device name	Cocoon Solo (DX-7020s)
Applicant	Dexcowin Global, Inc.
Product code	MUH
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	872.1800

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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Cocoon Solo (DX-7020s)

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