510(k) Report

FDA product code · Physical medicine

Attachment, Commode, Wheelchair

INBClass I21 CFR 890.3920510(k) exempt0 decisions0 recalls

FDA lists INB 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 INB 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 · INB

FDA has decided no INB device since 2007.

Median 510(k) review, days · INB

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

Recalls per year · INB

No recall names INB since 2007.

Adverse event reports per year · INB

2in 2024

2007: 112008: 82009: 142010: 122011: 202012: 822013: 72014: 32015: 12016: 12018: 12019: 22020: 12021: 12022: 32023: 12024: 2
2007high 82 (2012) · low 0 (2017)2025

MAUDE reports naming product code INB, 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—011
20080—08
20090—014
20100—012
20110—020
20120—082
20130—07
20140—03
20150—01
20160—01
20170—00
20180—01
20190—02
20200—01
20210—01
20220—03
20230—01
20240—02
20250—00
20260—0—
FIG. 1 — INB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in INB? 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 890.3920.