ITI · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3860
Classification
FDA Product Code
ITI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.3860
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 wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).