Walker, Mechanical, Poly Vinyl Chloride (Pvc)

NXE · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3825

Classification

FDA Product Code: NXE
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 890.3825
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 4
GMP exempt: Y
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown