FDA 510(k) K243442, iBOT® PMD, by Mobius Mobility
FDA 510(k) K243442, iBOT® PMD, by Mobius Mobility
Device Classification Name: Wheelchair, Stair Climbing
510(k) Number: K243442
Device Name: iBOT® PMD
Applicant: Mobius Mobility
Regulation Number: 890.389
Classification Product Code: IMK
Date Received: 2024-11-06
Decision Date: 2025-01-30
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
510k Review Panel: Physical Medicine
Total number of pages: 8,529
Fully redacted pages: 6,834
Content pages: 1,695
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