DeviceClearance

Product code ITI— Physical Medicine

POWERED WHEELCHAIR

Classification name
Wheelchair, Powered
Device class
Class 2
Regulation
21 CFR 890.3860
Advisory panel
Physical Medicine
Total cleared
588
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code ITI under 21 CFR 890.3860, via openFDA

Market context for product code ITI

FDA has cleared 588 devices under product code ITI between 1978 and 2026, filed by 260 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ITI

Adverse events under product code ITI

product code ITI
Death
34
Injury
778
Malfunction
1,085
Other
1
Total
1,898

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code ITI

1–100 of 588

Data sourced from openFDA. This site is unofficial and independent of the FDA.