DeviceClearance

Product code PCE— Physical Medicine

GARAVENTA X3 INCLINED PLATFORM LIFT

Classification name
Permanently Mounted Wheelchair Platform Lift
Device class
Class 2
Regulation
21 CFR 890.3930
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.”

— U.S. Food and Drug Administration, device classification record for product code PCE under 21 CFR 890.3930, via openFDA

Market context for product code PCE

FDA has cleared 1 device under product code PCE, all in 2013, filed by 1 applicant company. 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.

Top applicants under product code PCE

Recent clearances under product code PCE

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