NXE

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

Product code

NXE

Device name

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

Device class

Class 1

21 CFR

21 CFR 890.3825

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (last 3 years)

1

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).