ILK · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5150
Classification
FDA Product Code
ILK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.5150
Review panel
PM
Medical specialty
Physical Medicine
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.