510(k) Report

FDA product code · Orthopedic

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

LPQClass II21 CFR 890.5870510(k) required0 decisions since 19952 recalls

0 FDA decisions since 1995. 2 recalls name this code, 0 of them Class I.

A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference…

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, orthopedic panel

Twenty years of LPQ 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 · LPQ

1in 2015

2007: 32008: 22009: 22010: 12012: 12014: 42015: 1
2007high 4 (2014) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPQ

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

Recalls per year · LPQ

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPQ

1in 2015

2008: 22010: 12011: 42012: 42013: 32014: 12015: 1
2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code LPQ, 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
20073—00
20082—02
20092—20
20101—01
20110—04
20121—04
20130—03
20144—01
20151—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LPQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LPQ? 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 890.5870.