510(k) Report

FDA product code · Neurology

Foot Wrap For Treating Restless Leg Syndrome Symptoms

OTXClass I21 CFR 890.5760510(k) exempt1 decision0 recalls

FDA lists OTX as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision. No recall names this code. The most-cited predicate is DEN110009, named by 1 later device.

Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.

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

Planning a device in OTX? 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 OTX devices cite most?

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

  • DEN110009Foot Wrap For Treating Restless Leg Syndrome Symptoms1cites it