DeviceClearance

Product code ILK— Physical Medicine

PATIENT MOVER(TM)

Classification name
Transport, Patient, Powered
Device class
Class 2
Regulation
21 CFR 890.5150
Advisory panel
Physical Medicine
Total cleared
36
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code ILK under 21 CFR 890.5150, via openFDA

Market context for product code ILK

FDA has cleared 36 devices under product code ILK between 1977 and 2024, filed by 25 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 ILK

Recent clearances under product code ILK

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