Wheelchair, Mechanical

IOR · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3850

Classification

FDA Product Code: IOR
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 890.3850
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 455
Registered establishments: 127

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown