iBOT® PMD

The iBOT® PMD is a multi-mode powered wheelchair that enables users to maneuver in confined spaces, climb stairs and curbs, and traverse difficult terrain. It provides indoor and outdoor mobility to persons restricted to a sitting position, with optional stair-climbing capability and elevated seat height functionality. Users or trained assistants must complete a certification program and meet specific user assessment requirements.

The proposed device maintains the same fundamental architecture, drive system, battery specifications, and operating modes as the predicate K210920. Key updates include an optional Motion Concepts Modular Power Positioning Seating System with powered tilt, recline, and elevating legrests; anterior tilt capability; power seat elevation in Standard Mode; optional 4-inch drive wheels; minor caster redesign; and removal of the mechanical ventilator contraindication. Weight capacity is reduced to 275 lb when power positioning options are used.

ISO 7176 series (Parts 1-6, 8-11, 13-15, 19, 21-22, 25, 28, 30); IEC 62133-2:2021; ISO 10993 series (Parts 1, 3, 5, 10); ANSI RESNA WC-1:2019; IEC 62304; UL 2054:2021; EN 1021 series; California Technical Bulletin 117-2013; UN 38.3; and AIM 7351731.

The proposed device retains all fundamental technological characteristics, system architecture, and operating principles of the predicate device. Design modifications add optional seating features (K150574) and expand power positioning capabilities without changing core safety or stability mechanisms. Performance testing to current standard versions demonstrates equivalent safety and effectiveness, with risk mitigations for new features verified through FMEA and validation. Updated indications for use and contraindications merely clarify operator eligibility and weight limits reflective of available configurations, not new intended uses.