DeviceClearance

Product code IOR— Physical Medicine

MANUAL WHEELCHAIR

Classification name
Wheelchair, Mechanical
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Total cleared
463
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code IOR under 21 CFR 890.3850, via openFDA

Market context for product code IOR

FDA has cleared 463 devices under product code IOR between 1978 and 2026, filed by 264 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code IOR

Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

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 IOR

1–100 of 463

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