Name: Predicase
Price: 199 USD

K-number	K250576
Device name	Flexx Junior (FLX-J00, FLX-J50)
Applicant	Karma Mobility Co, Ltd.
Product code	IOR
Device class	Class I
Decision date	Nov 4, 2025
Decision	Substantially Equivalent
Regulation	890.3850

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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Flexx Junior (FLX-J00, FLX-J50)

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