510(k) Report

FDA product code · Physical medicine

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

NXEClass I21 CFR 890.3825510(k) exempt1 decision since 20050 recalls

FDA lists NXE as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2005. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, physical medicine panel

Twenty years of NXE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NXE

FDA has decided no NXE device since 2007.

Median 510(k) review, days · NXE

Too few NXE 510(k)s in any year since 2007 to give a median.

Recalls per year · NXE

No recall names NXE since 2007.

Adverse event reports per year · NXE

1in 2019

2007: 32012: 52013: 12019: 1
2007high 5 (2012) · low 0 (2008)2025

MAUDE reports naming product code NXE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—00
20090—00
20100—00
20110—00
20120—05
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NXE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NXE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in NXE lately?

  • K053192Model 418 Series WalkersMjm International Corporation · 2005

The one NXE decision →

Related product codes

Other codes under 21 CFR 890.3825.

ITJ Walker, Mechanical