FDA product code · Physical medicine

Stimulator, Muscle, Diagnostic

Name: FDA decisions, review times, recalls and adverse event reports for product code ISB
Creator: 510(k) Report

ISBClass II21 CFR 890.1850510(k) required5 decisions since 19780 recalls

5 FDA decisions since 1978. 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 ISB 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 · ISB

FDA has decided no ISB device since 2007.

Median 510(k) review, days · ISB

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

Recalls per year · ISB

No recall names ISB since 2007.

Adverse event reports per year · ISB

No MAUDE report names ISB since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — ISB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ISB? 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

Stimulator, Muscle, Diagnostic

What has FDA decided in ISB lately?