FDA product code · Physical medicine

Stimulator, Functional Neuromuscular, Scoliosis

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

LWBClass IIIPMA required1 decision since 19830 recalls

1 FDA decision since 1983. 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 LWB 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 · LWB

FDA has decided no LWB device since 2007.

Median 510(k) review, days · LWB

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

Recalls per year · LWB

No recall names LWB since 2007.

Adverse event reports per year · LWB

No MAUDE report names LWB 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 — LWB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LWB? 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, Functional Neuromuscular, Scoliosis

What has FDA decided in LWB lately?