510(k) Report

De Novo · Granted

Granted

Foot Wrap For Treating Restless Leg Syndrome Symptoms

DEN110009De NovoClass I21 CFR 890.5760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unknown applicant · OTX Foot Wrap For Treating Restless Leg Syndrome Symptoms

Granted as a new device type through De Novo. 1 later device descends from it.

Class
Class I
Product code
OTX
Recalls
None

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared
  1. This deviceDEN110009 Foot Wrap For Treating Restless Leg Syndrome Symptoms ·
  2. Descendant · cites it directly · 0 of its ownK191933 COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control…Johnson & Johnson Surgical Vision, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV…Johnson & Johnson Surgical Vision, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN110009Foot Wrap For Treating Restless Leg Syndrome Symptoms—
+1K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT…Johnson & Johnson Surgical Vision, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of DEN110009, –2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OTX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV…Johnson & Johnson Surgical Vision, Inc.20190

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K191933 (Johnson & Johnson Surgical Vision, Inc., 2019) has gone furthest, with 0 descendants of its own.

https://510kreport.com/device/DEN110009 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN110009: Foot Wrap For Treating Restless Leg Syndrome Symptoms.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN110009

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026