Cleared Traditional

MODEL 418 SERIES WALKERS (K053192) - FDA 510(k) Clearance

Class I Physical Medicine device.

K053192 · Mjm International Corporation · Physical Medicine device
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Dec 2005
Decision
20d
Days
Class 1
Risk

K053192 is an FDA 510(k) clearance for the MODEL 418 SERIES WALKERS. Classified as Walker, Mechanical, Poly Vinyl Chloride (pvc) (product code NXE), Class I - General Controls.

Submitted by Mjm International Corporation (San Juan, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3825 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mjm International Corporation devices

Submission Details

510(k) Number K053192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2005
Decision Date December 05, 2005
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NXE Walker, Mechanical, Poly Vinyl Chloride (pvc)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3825
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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.