Name: Predicase
Price: 199 USD

K-number	K250819
Device name	Electric Wheelchair (Rollz Motion Electric 2M)
Applicant	Rollz International BV
Product code	ITI
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	890.3860

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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Electric Wheelchair (Rollz Motion Electric 2M)

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