510(k) Report

FDA product code · Neurology

Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

OSGClass II21 CFR 882.5894510(k) exempt2 decisions0 recalls

FDA lists OSG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions. No recall names this code. The most-cited predicate is DEN100024, named by 1 later device.

Relief / Reduction of Mosquito Bite Itch

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, neurology panel

Twenty years of OSG 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.

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

Planning a device in OSG? 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

Which predicates do OSG devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN100024Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch1cites it