DeviceClearance

Product code NXE— Physical Medicine

MODEL 418 SERIES WALKERS

Classification name
Walker, Mechanical, Poly Vinyl Chloride (Pvc)
Device class
Class 1
Regulation
21 CFR 890.3825
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.”

— U.S. Food and Drug Administration, device classification record for product code NXE under 21 CFR 890.3825, via openFDA

Market context for product code NXE

FDA has cleared 1 device under product code NXE, all in 2005, filed by 1 applicant company. 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.

Top applicants under product code NXE

Recent clearances under product code NXE

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