510(k) Report

FDA product code · Physical medicine

Electromagnetic Stimulator, Pain Relief

QPLClass II21 CFR 882.5890510(k) required6 decisions since 20210 recalls

6 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 172 days (half between 154 and 222). No recall names this code. The most-cited predicate is K230014, named by 3 later devices.

Intended to apply a magnetic-field induced electrical current to treat pain.

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 QPL 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 · QPL

3in 2025

2021: 12023: 12024: 12025: 3
2007high 3 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPL

185in 2025

2025: 185 days median
2007high 185 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QPL

No recall names QPL since 2007.

Adverse event reports per year · QPL

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code QPL, 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—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
20211—01
20220—00
20231—00
20241—00
2025318500
20260—0—
FIG. 1 — QPL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QPL? 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 882.5890.