Wheelchair, Stair Climbing

IMK · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3890

Classification

FDA Product Code: IMK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.3890
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. 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 require an assistive device for mobility.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 2

Source

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