Walker, Mechanical, Poly Vinyl Chloride (Pvc)
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong and Hebei: 2 hold an FDA registration.
What Is It?
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.
What Is FDA Product Code NXE?
Walker, Mechanical, Poly Vinyl Chloride (Pvc) is FDA product code NXE, Class 1, 21 CFR 890.3825.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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