510(k) Report

FDA product code · Physical medicine

Holder, Crutch And Cane, Wheelchair

IMZClass I21 CFR 890.3910510(k) exempt0 decisions0 recalls

FDA lists IMZ 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. 0 FDA decisions. No recall names this code.

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 IMZ 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 · IMZ

FDA has decided no IMZ device since 2007.

Median 510(k) review, days · IMZ

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

Recalls per year · IMZ

No recall names IMZ since 2007.

Adverse event reports per year · IMZ

No MAUDE report names IMZ since 2007.

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

Planning a device in IMZ? 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

Related product codes

Other codes under 21 CFR 890.3910.

KID Restraint, Wheelchair, Non-ProtectiveINC Cuff, Pusher, WheelchairKNO Accessories, WheelchairIMS Support, Head And Trunk, WheelchairIMX Board, Lap, WheelchairINE Sling, Overhead Suspension, WheelchairIMY Armboard, Wheelchair