IOR

463 FDA 510(k) clearances · Product code

FDA profile

Official device name

Wheelchair, Mechanical

Device class

Class I (low risk)

Regulation

21 CFR 890.3850

Medical specialty

Physical Medicine

Flags

Third-party review eligible

FDA definition

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.

Adverse events (MAUDE)

2021: 59 · 2022: 37 · 2023: 165 · 2024: 138 · 2025: 138 · 2026: 715
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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