510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053192Substantially Equivalent

Model 418 Series Walkers

MJM International Corporation, San Juan TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053192 is the FDA 510(k) clearance record for MODEL 418 SERIES WALKERS, a class I device, cleared for Mjm International Corporation on under FDA product code NXE (Walker, Mechanical, Poly Vinyl Chloride (Pvc)). FDA's definition for product code NXE reads: "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...". FDA records list one 510(k) clearance for Mjm International Corporation. As of , FDA records show no recalls naming K053192.

Clearance record

Decision date
Received
(20 days to decision)
Product code
NXE Walker, Mechanical, Poly Vinyl Chloride (Pvc)
Regulation
21 CFR 890.3825
Device class
Class I
Review panel
Physical Medicine
Applicant
Mjm International Corporation 2003 N. I Rd., Suite 10, San Juan TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXE

Trailing 12 months

FDA records hold no clearances under product code NXE in the trailing twelve months.

FDA records show no clearances under product code NXE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NXE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260