Name: Predicase
Price: 199 USD

K-number	K243981
Device name	Hexoskin Medical System (7100-00016)
Applicant	Carre Technologies, Inc.
Product code	DXH
Device class	Class II
Decision date	Nov 18, 2025
Decision	Substantially Equivalent
Regulation	870.2920

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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Hexoskin Medical System (7100-00016)

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