NXE

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

Device class

Class I (low risk)

Regulation

21 CFR 890.3825

Medical specialty

Physical Medicine

Flags

GMP exempt

FDA 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.

Adverse events (MAUDE)

2007: 3 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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